ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent — Class II medical device recall Z-2739-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2015-09-16, distributed nationwide. Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA
| Recall number | Z-2739-2015 |
|---|---|
| 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 | 2015-07-27 |
| Classified | 2015-09-04 |
| Reported by FDA | 2015-09-16 |
| Terminated | 2016-02-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, DE, EE, ES, FI, FR, GB, IE, IT, PK, SE, TR |
| Quantity | 466 |
| Reason classes | potency |
| Lot numbers | 54942, 56230, 70673 |
Product
ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
Reason for recall
Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.
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-2739-2015. 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.