Qiagen recalls
3 official recalls and safety alerts involving Qiagen since 2023-08, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Qiagen or the relevant agency.
- 2023-10-11
USQiagen GmbH recalls therascreen ¿KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic…
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…
FDA · DeviceQiagen GmbHWorldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN,…Official notice →- 2023-08-02
- US
Qiagen GmbH recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients…
Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
FDA · DeviceQiagen GmbHDC, AL, CA, FL, GA, ME, NC, NY, OR, TX Foreign: DE, AE, AT, BE, BG, CH, CL,…Official notice → - US
Qiagen GmbH recalls QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the…
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…
FDA · DeviceQiagen GmbHAL, AR, CA, DC, FL, GA, ID, KS, KY, MD, MN, NJ, NY,PA, SC, TX, VAOfficial notice →