ADVIA Centaur HCY Diluent — Class II medical device recall Z-1960-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2014-07-09, distributed nationwide. ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patie
| Recall number | Z-1960-2014 |
|---|---|
| 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 | 2013-06-25 |
| Classified | 2014-07-02 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2016-05-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, BG, CH, CY, CZ, DE, DK, ES, FI, FR, GB, GR, HR, HU, IE, IT, LU, LV, NL, NO, PL, PT, RO, RS, SA, SE, SK, TR |
| Quantity | 51 units |
| Lot numbers | 88D1524, 88D3303 |
| Model numbers | 03302138, 09877493 |
Product
ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.
Reason for recall
ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the Instructions for Use (IFU).
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-1960-2014. 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.