--- title: "Microbiologics Inc Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Microbiologics Inc recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/microbiologics-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Microbiologics Inc recall records **17** reported ongoing 23 records in this archive. Latest source date Dec 2, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Dec 2, 2025 FDA device enforcement ### [KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P](https://isitonrecall.com/recall/fda-device-z-0984-2026-kwik-stik-2-pack-campylobacter-jejuni-subsp-jejuni-derived-from-atcc-29428-catalog-number-0325p/) Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. Class II Reported ongoing Distribution: Worldwide - US Nationwide. [Official source for KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0984-2026%22) Dec 2, 2025 FDA device enforcement ### [KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K](https://isitonrecall.com/recall/fda-device-z-0985-2026-kwik-stik-6-pack-campylobacter-jejuni-subsp-jejuni-derived-from-atcc-29428-catalog-number-0325k/) Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. Class II Reported ongoing Distribution: Worldwide - US Nationwide. [Official source for KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0985-2026%22) Dec 2, 2025 FDA device enforcement ### [LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L](https://isitonrecall.com/recall/fda-device-z-0986-2026-lyfo-disk-campylobacter-jejuni-subsp-jejuni-derived-from-atcc-29428-catalog-number-0325l/) Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. Class II Reported ongoing Distribution: Worldwide - US Nationwide. [Official source for LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0986-2026%22) Nov 13, 2025 FDA device enforcement ### [KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K](https://isitonrecall.com/recall/fda-device-z-0876-2026-kwik-stik-quality-control-kit-for-culture-media-vibrio-parahaemolyticus-derived-from-atcc-17802-cata/) Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10. Class II Reported ongoing Distribution: International distribution to the countries of UAE, China, Singapore, Kazakhstan, [Official source for KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0876-2026%22) Jun 27, 2025 FDA device enforcement ### [LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)](https://isitonrecall.com/recall/fda-device-z-2194-2025-lyfo-disk-m-canis-derived-from-atcc-36299-packaged-as-1-ref-0894k-6-pack-2-ref-0894p-2-pack/) KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of France, Colombia, Philippines, Peru, Turkey, India, Finland, Trinidad and Tobago, Poland, Viet Nam, Brazil, Japan, Ma... [Official source for LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2194-2025%22) Jun 27, 2025 FDA device enforcement ### [LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L](https://isitonrecall.com/recall/fda-device-z-2195-2025-lyfo-disk-m-canis-derived-from-atcc-36299-packaged-as-1-ref-0894l/) KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of France, Colombia, Philippines, Peru, Turkey, India, Finland, Trinidad and Tobago, Poland, Viet Nam, Brazil, Japan, Ma... [Official source for LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2195-2025%22) Jun 17, 2025 FDA device enforcement ### [KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L](https://isitonrecall.com/recall/fda-device-z-2124-2025-kwik-stik-and-lyfo-disk-quality-control-kit-for-culture-media-catalog-0805k-and-0805l/) Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient. Class II Reported ongoing Distribution: US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh. [Official source for KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2124-2025%22) May 27, 2025 FDA device enforcement ### [KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493](https://isitonrecall.com/recall/fda-device-z-1957-2025-kwik-stick-quality-control-kit-for-culture-media-catalog-numbers-01065k-oligella-urethralis-derived/) Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packaged with 0621K swabs. This may lead to delayed diagnosis. Class II Reported ongoing Distribution: US Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand. [Official source for KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis de...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1957-2025%22) Feb 20, 2025 FDA device enforcement ### [Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N](https://isitonrecall.com/recall/fda-device-z-1371-2025-helix-elite-inactivated-standard-inactivated-sars-cov-2-whole-virus-pellet-multi-analyte-unassayed-q/) The A549 human cell target (human cells for sample adequacy control) may give a late Ct value. Class II Reported ongoing Distribution: US Nationwide distribution in the states of TX. UK. [Official source for Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, un...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1371-2025%22) Feb 20, 2025 FDA device enforcement ### [Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N](https://isitonrecall.com/recall/fda-device-z-1454-2025-helix-elite-inactivated-standard-inactivated-influenza-a-b-and-respiratory-syncytial-virus-multi-ana/) The RSV target may give a late Ct value and could potentially not pass QC. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK. [Official source for Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Mult...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1454-2025%22) Jan 20, 2025 FDA device enforcement ### [Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test](https://isitonrecall.com/recall/fda-device-z-1163-2025-microbiologics-multi-strain-human-papillomavirus-hpv-control-panel-inactivated-pellet-ref-8234-in-vi/) Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enou... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand. [Official source for Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 82...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1163-2025%22) Jan 20, 2025 FDA device enforcement ### [Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test](https://isitonrecall.com/recall/fda-device-z-1164-2025-microbiologics-multi-strain-human-papillomavirus-hpv-verification-panel-inactivated-pellet-ref-8235/) Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enou... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand. [Official source for Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), R...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1164-2025%22) Mar 6, 2024 FDA device enforcement ### [KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media](https://isitonrecall.com/recall/fda-device-z-1483-2024-kwik-stik-rhizopus-stolonifer-derived-from-atcc-6227b-a-ref-0209p-and-b-ref-0209k-quality-control-ki/) The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may observe A. brasiliensis growth when using the control material. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CA, MI, KY, MO, NM, TN, PR, and the countries of France, Columbia, Kazakhstan, Peru, Puerto Rico, South Africa. [Official source for KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1483-2024%22) Jan 8, 2024 FDA device enforcement ### [Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.](https://isitonrecall.com/recall/fda-device-z-1075-2024-microbiologics-enteric-pathogens-control-panel-inactivated-pellet-ref-8184/) The negative control was contaminated with one of the positive control pathogens (Norovirus). This would result in users getting a positive call for Norovirus when running the negative control. Class II Reported ongoing Distribution: US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NE, NH, NJ, NY, OH, PA, RI, TN, TX, VA, WA, WI, WV, a... [Official source for Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1075-2024%22) Oct 18, 2023 FDA device enforcement ### [KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)](https://isitonrecall.com/recall/fda-device-z-0307-2024-kwikstik-p-venetum-catalog-numbers-a-0794p-2-pack-b-0794k-6-pack/) A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico. [Official source for KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0307-2024%22) Oct 18, 2023 FDA device enforcement ### [LYFO-DISK, P. venetum, Catalog number 0794L](https://isitonrecall.com/recall/fda-device-z-0308-2024-lyfo-disk-p-venetum-catalog-number-0794l/) A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico. [Official source for LYFO-DISK, P. venetum, Catalog number 0794L](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0308-2024%22) Aug 14, 2023 FDA device enforcement ### [KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing](https://isitonrecall.com/recall/fda-device-z-2576-2023-kwik-stik-ana-3-strains-qc-set-ref-5065p-microbiological-testing/) One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis. Class III Reported ongoing Distribution: US Nationwide distribution in the states of MN, PA, TN, TX. [Official source for KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2576-2023%22) Jul 27, 2022 FDA device enforcement ### [Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N](https://isitonrecall.com/recall/fda-device-z-1740-2022-helix-elite-inactivated-standard-labeled-as-a-inactivated-sars-cov-2-b-1-1-7-whole-virus-ref-he0071n/) Product not registered for use in the UK Class III Reported terminated Distribution: International distribution to the country of United Kingdom. [Official source for Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1740-2022%22) May 6, 2022 FDA device enforcement ### [KWIK-STIK" plus: Clostridium perfringens](https://isitonrecall.com/recall/fda-device-z-1125-2022-kwik-stik-plus-clostridium-perfringens/) Labeling error. Class III Reported terminated Distribution: Distributed US Nationwide to IA, TN and internationally to Mexico, Colombia, France, South Africa, United Kingdom. [Official source for KWIK-STIK" plus: Clostridium perfringens](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1125-2022%22) Mar 24, 2022 FDA device enforcement ### [Inactivated macrolide and quinolone-resistant Mycoplasma genitalium](https://isitonrecall.com/recall/fda-device-z-0954-2022-inactivated-macrolide-and-quinolone-resistant-mycoplasma-genitalium/) QC process was not adequate for the specification range. Class II Reported terminated Distribution: US Nationwide distribution in the state of TX. [Official source for Inactivated macrolide and quinolone-resistant Mycoplasma genitalium](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0954-2022%22) ## Reasons in these listed records - Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. - Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10. - KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted. - Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient. These examples come from this result page and are not a ranking of every recall reason. ## Checking Microbiologics Inc ### Is there a recall on microbiologics inc right now? This archive contains 23 records, including 17 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Microbiologics Inc](https://isitonrecall.com/check/?q=Microbiologics%20Inc) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)