Reported Oct 26, 2022 · Ongoing
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
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 CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
- Lot codes and dates
- UDI-DI00630414006789
- All lots impactedLots 110354 exp 11/15/22 120038 exp 2/7/23
- Amount recalled
- 586 US; 694 OUS
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
- Nationwide
Why it was recalled
Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy.
This product could cause temporary or reversible health problems — stop using it.
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