--- title: "Qiagen Sciences LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Qiagen Sciences LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/qiagen-sciences-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Qiagen Sciences LLC recall records **10** reported ongoing 11 records in this archive. Latest source date Mar 12, 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 Mar 12, 2025 FDA device enforcement ### [Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a](https://isitonrecall.com/recall/fda-device-z-1504-2025-brand-name-qiastat-dx-product-name-qiastat-dx-respiratory-panel-plus-reference-number-ref-691224-sof/) Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur. Class II Reported ongoing Distribution: US Distribution: AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, and TX. [Official source for Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 69...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1504-2025%22) Jun 3, 2024 FDA device enforcement ### [QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Mod...](https://isitonrecall.com/recall/fda-device-z-2353-2024-qiacube-connect-mdx-ivd-instrument-designed-to-perform-automated-isolation-and-purification-of-nucle/) Heater shaker module does not perform heating if the temperature is set below 40¿C for static incubation steps when running IVD protocol QIAamp¿ DSP DNA Mini Kit (cat. no. 61304), Protocol: Isolation of genomic DNA from Gram-positive bacteria (Script filena... Class II Reported ongoing Distribution: Nationwide. Foreign: AD, AT, AU, BE, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, ID, IN, IT, JO, KR, KZ, LU, ML, MY, NL, NO, PH, PL, PY, SA, SE, SG, SK, SO, VN J, NV, NY, OH, OK, OR... [Official source for QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2353-2024%22) Mar 4, 2024 FDA device enforcement ### [EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230](https://isitonrecall.com/recall/fda-device-z-1508-2024-ez2-connect-mdx-ivd-designed-to-perform-automated-isolation-and-purification-of-nucleic-acids-in-mol/) Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost Class II Reported ongoing Distribution: Nationwide Foreign: AT, AU, BE, CH, CR, CZ, DE, DK, ES, FR, GB, HU, IT, JO, NL, NO, QA, SA, SE, SI, TH [Official source for EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1508-2024%22) Apr 28, 2023 FDA device enforcement ### [QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223](https://isitonrecall.com/recall/fda-device-z-1683-2023-qiastat-dx-respiratory-sars-cov-2-panel-multiplexed-nucleic-acid-real-time-pcr-test-reference-number/) Faulty cartridges in the lot could result in false test results. Class II Reported ongoing Distribution: US Nationwide distribution in the states of CA, FL, IL, MD, MS, NY, OK, PA, TN. [Official source for QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Nu...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1683-2023%22) Jul 20, 2022 FDA device enforcement ### [therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721](https://isitonrecall.com/recall/fda-device-z-1650-2022-therascreen-fgfr-rgq-rt-pcr-kit-us-ivd-ref-874721/) Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate ... Class II Reported ongoing Distribution: IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand [Official source for therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1650-2022%22) Jul 20, 2022 FDA device enforcement ### [therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711](https://isitonrecall.com/recall/fda-device-z-1651-2022-therascreen-fgfr-rgq-rt-pcr-kit-ce-ivd-not-sold-in-the-us-ref-874711/) Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate ... Class II Reported ongoing Distribution: IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand [Official source for therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1651-2022%22) Jul 20, 2022 FDA device enforcement ### [FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010](https://isitonrecall.com/recall/fda-device-z-1652-2022-fgfr-rgq-rt-pcr-kit-ruo-not-ivd-ref-8747010/) Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate ... Class II Reported ongoing Distribution: IN, NC, MN, TX Foreign: Belgium, China, Germany, Jordan, Italy, Netherlands, Malaysia, Spain, Thailand [Official source for FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1652-2022%22) Feb 25, 2022 FDA device enforcement ### [therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)](https://isitonrecall.com/recall/fda-device-z-0951-2022-therascreen-kras-rgq-pcr-kit-24-model-number-s-ref-870021-us-ivd/) False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit. Class II Reported ongoing Distribution: AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV [Official source for therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0951-2022%22) Feb 25, 2022 FDA device enforcement ### [therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)](https://isitonrecall.com/recall/fda-device-z-0952-2022-therascreen-kras-rgq-pcr-kit-24-ref-874052-japan-ivd-not-released-in-the-usa/) False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit. Class II Reported ongoing Distribution: AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV [Official source for therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0952-2022%22) Nov 21, 2021 FDA device enforcement ### [QIAcube Connect MDx, Model No. 9003070](https://isitonrecall.com/recall/fda-device-z-1746-2022-qiacube-connect-mdx-model-no-9003070/) During the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to over diluted, unde... Class II Reported ongoing Distribution: Domestic distribution to AZ, CA, CO, DE, DC, FL, GA, IA, KS, LA, MA, MD, MN, NV, NJ, NY, NC, OH, PA, SC, SD, TN, TX, VA, WA, WI. International distribution worldwide. [Official source for QIAcube Connect MDx, Model No. 9003070](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1746-2022%22) Nov 8, 2021 FDA device enforcement ### [QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223](https://isitonrecall.com/recall/fda-device-z-0455-2022-qiastat-dx-respiratory-sars-cov-2-panel-us-ivd-under-fda-eua-200075-ref-691223/) The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could ... Class II Reported terminated Distribution: Domestic distribution to AL, DC, KY, MD, ME, NJ, OK< PA, and TX. No foreign distribution. [Official source for QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0455-2022%22) ## Reasons in these listed records - Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur. - Heater shaker module does not perform heating if the temperature is set below 40¿C for static incubation steps when running IVD protocol QIAamp¿ DSP DNA Mini Kit (cat. no. 61304), Protocol: Isolation of genomic DNA from Gram-positive bacteria (Script filename: Kt\_name\_Bacteria... - Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost - Faulty cartridges in the lot could result in false test results. These examples come from this result page and are not a ranking of every recall reason. ## Checking Qiagen Sciences LLC ### Is there a recall on qiagen sciences llc right now? This archive contains 11 records, including 10 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 Qiagen Sciences LLC](https://isitonrecall.com/check/?q=Qiagen%20Sciences%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)