ADVIA Centaur Vitamin D Assay — Class II medical device recall Z-1119-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2013-04-24, distributed nationwide. Negative bias in patient samples for Vitamin D
| Recall number | Z-1119-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2013-03-13 |
| Classified | 2013-04-15 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2015-03-05 |
| Distributed | Nationwide (US) |
| Quantity | 3,871 |
| Lot numbers | 134009, 134010, 134011, 88766009, 88786009, 89198009, 90671010, 92212010, 92395011, 94660011, 95016011, 95313011 |
Product
ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D.
Reason for recall
Negative bias in patient samples for Vitamin D
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1119-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.