Reported Oct 9, 2024 · Ongoing
Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
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. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
- Lot codes and dates
- UDI-DIMaterial Number 10995466 (100 Test) - 00630414597935; Material Number 10995467 (500 Test) - 00630414597942
- Lot Number26098336 26099336
- Amount recalled
- 9783 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
- Nationwide
Why it was recalled
Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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