Qiagen recalls
Qiagen appears in 6 official U.S. recall notices indexed by RecallRadar, most recently on 2023-10-11.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 6 |
|---|---|
| Published | 2017-12-27 to 2023-10-11 |
| By agency | FDA Device (6) |
| By classification | Class II (6) |
| By status | ongoing (4), terminated (2) |
| Distribution named in notices | AL, AR, CA, DC, DE, FL, GA, ID, IN, KS, KY, MD, ME, MN, NC, NJ, NY, OR, PA, SC, TN, TX, US, VA |
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 mut…
FDA Device · Class II · 2023-10-11 · Qiagen
Reason: 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 m… - QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the follow…
FDA Device · Class II · 2023-08-02 · Qiagen
Reason: 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 rep… - QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients sus…
FDA Device · Class II · 2023-08-02 · Qiagen
Reason: Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated - 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 nasoph…
FDA Device · Class II · 2023-08-02 · Qiagen
Reason: Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated - EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use
FDA Device · Class II · 2018-08-08 · Qiagen
Reason: Underfilled reagent well that could lead to incorrect results - QIAamp DSP Virus Kit Cat
FDA Device · Class II · 2017-12-27 · Qiagen
Reason: Certain lots of the QIAamp DSP Virus Kit, REF 60704, used in analytic workflows could result in decreased performance.