Reported Nov 10, 2021 · Terminated
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
Siemens Healthcare Diagnostics, Inc.
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: Siemens Healthcare Diagnostics, Inc · 333 Coney St · East Walpole, MA · 02032-1516
Is this the product you have?
- Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
- Lot codes and dates
- Lot # 44989001 - Exp. Date 2021-10-07, UDI # (01)00630414611846(10)44989001(17)20211007; Lot # 60407003 - Exp. Date 2021-03-22, UDI # (01)00630414611846(10)60407003(17)20211112.
- Amount recalled
- 149 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
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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