Reported Jun 4, 2025 · Ongoing
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
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?
- ADVIA Centaur HCY Calibrator (2 Pack)
- Siemens Material Number10310376
- Lot codes and dates
- Siemens Material Number10310376
- UDI-DI 00630414468198 Kit lot numbers86237A74, 44207A75. ***Updated 5/8/26*** Additional lots 25674A77 52363A79
- Amount recalled
- 1,072 packs (2,144 units) - 156 packs US, 916 packs OUS
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
Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.
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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