Reported Aug 2, 2023 · Ongoing
QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended…
Qiagen GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Qiagen GmbH · Qiagen Str. 1 · Hilden, N/A · N/A
Is this the product you have?
- 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 patients
- suspected of respiratory infection REF691214
- Lot codes and dates
- LOT Numbers
LOTs 172043034172043348172043349172043369172044712172048091172048388172048394172048396175010065175010066175010086175010669172046775172048381 Exp
- Date2023-10-06 and 2023-10-17
- LOT Numbers
- Amount recalled
- 4155 kits
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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