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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. Source coverage and dates.
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide.
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide.
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide.
Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
Class IIReported ongoing
Distribution: International distribution to the countries of UAE, China, Singapore, Kazakhstan,
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 IIReported 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...
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 IIReported 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...
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 IIReported ongoing
Distribution: US distribution to states of: Utah and Ohio; and OUS (International) to countries of: Italy, Netherlands, Argentina, Korea, Jordan, Spain, and Bangladesh.
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 IIReported ongoing
Distribution: US Nationwide distribution in the states of California and Pennsylvania and the country of New Zealand.
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of TX. UK.
The RSV target may give a late Ct value and could potentially not pass QC.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK.
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 IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.
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 IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.
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 IIReported 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.
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 IIReported 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...
A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.
A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Italy, France, Turkey, Peru, Mexico.
One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides distasonis.
Class IIIReported ongoing
Distribution: US Nationwide distribution in the states of MN, PA, TN, TX.
Product not registered for use in the UK
Class IIIReported terminated
Distribution: International distribution to the country of United Kingdom.
Labeling error.
Class IIIReported terminated
Distribution: Distributed US Nationwide to IA, TN and internationally to Mexico, Colombia, France, South Africa, United Kingdom.
QC process was not adequate for the specification range.
Class IIReported terminated
Distribution: US Nationwide distribution in the state of TX.
These examples come from this result page and are not a ranking of every recall reason.
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.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
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.
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 and the agency's current notices.
Use monthly 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.