--- title: "Qiagen GmbH Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Qiagen GmbH 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-gmbh/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Qiagen GmbH recall records **4** reported ongoing 4 records in this archive. Latest source date Aug 22, 2023. 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 Aug 22, 2023 FDA device enforcement ### [therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF ...](https://isitonrecall.com/recall/fda-device-z-2665-2023-therascreen-kras-rgq-pcr-kit-24-ivd-qualitative-pcr-assay-used-on-the-rotor-gene-q-mdx-instrument-fo/) Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE\_INT\_CTRL\_FAIL. A dilution of CRC tissue could lead to a false negative result. To remove ambiguity, an alteration must be made to the S the sample result with th... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN, KS, MA, NC,NY,OR, PA, TN, TX and the countries of KR, CN [Official source for therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrum...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2665-2023%22) May 19, 2023 FDA device enforcement ### [QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for th...](https://isitonrecall.com/recall/fda-device-z-2245-2023-qiastat-dx-respiratory-sars-cov-2-panel-us-ivd-qualitative-test-intended-for-analyzing-nasopharyngea/) Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated Class II Reported ongoing Distribution: DC, AL, CA, FL, GA, ME, NC, NY, OR, TX Foreign: DE, AE, AT, BE, BG, CH, CL, CY, CZ, DE, DK, ES, FI, FR, GB, GR, GT, HK, HU, ID, IN, IT, JO, MC, MU, MY, NL, NA, PL, PT, RO, SE, S... [Official source for QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasophary...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2245-2023%22) May 19, 2023 FDA device enforcement ### [QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patie...](https://isitonrecall.com/recall/fda-device-z-2246-2023-qiastat-dx-respiratory-sars-cov-2-panel-v1-and-v2-ce-ivd-not-us-ivd-not-sold-in-the-us-qualitative-t/) Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated Class II Reported ongoing Distribution: DC, AL, CA, FL, GA, ME, NC, NY, OR, TX Foreign: DE, AE, AT, BE, BG, CH, CL, CY, CZ, DE, DK, ES, FI, FR, GB, GR, GT, HK, HU, ID, IN, IT, JO, MC, MU, MY, NL, NA, PL, PT, RO, SE, S... [Official source for QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qual...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2246-2023%22) May 9, 2023 FDA device enforcement ### [QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adeno...](https://isitonrecall.com/recall/fda-device-z-2215-2023-qiastat-dx-respiratory-sars-cov-2-panel-ivd-intended-for-the-detection-and-differentiation-of-nuclei/) If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that lead to a run abortion will occur and no results will be reported Class II Reported ongoing Distribution: AL, AR, CA, DC, FL, GA, ID, KS, KY, MD, MN, NJ, NY,PA, SC, TX, VA [Official source for QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of n...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2215-2023%22) ## Reasons in these listed records - Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE\_INT\_CTRL\_FAIL. A dilution of CRC tissue could lead to a false negative result. To remove ambiguity, an alteration must be made to the S the sample result with this flag should be in... - Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated - If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that lead to a run abortion will occur and no results will be reported These examples come from this result page and are not a ranking of every recall reason. ## Checking Qiagen GmbH ### Is there a recall on qiagen gmbh right now? This archive contains 4 records, including 4 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 GmbH](https://isitonrecall.com/check/?q=Qiagen%20GmbH) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)