Reported Aug 2, 2023 · Ongoing
QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from…
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 -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the
- following organism types and subtypes
AdenovirusCoronavirus 229ECoronavirus HKU1Coronavirus NL63Coronavirus OC43SARS-CoV-2Human Metapneumovirus A+BInfluenza AInfluenza A H1Influenza A H3Influenza A H1N1/pdm09Influenza BParainfluenza virus 1Parainfluenza virus 2Parainfluenza virus 3Parainfluenza virus 4Rhinovirus/EnterovirusRespiratory Syncytial Virus A+BBordetella pertussisChlamydophila pneumoniaeand Mycoplasma pneumoniae REF 691223
- Lot codes and dates
- GTIN14053228038846
- LOT Number175010712 Affected Serial numbers (SNs) are from 330559516 to 330559783
- Amount recalled
- 368 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
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
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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