Siemens Healthcare ADVIA Centaur DHEA-504 — Class II medical device recall Z-0509-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2012-12-19, distributed nationwide. Operating range of the ADVIA Centaur systems is 18C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature m
| Recall number | Z-0509-2013 |
|---|---|
| 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 | 2012-11-14 |
| Classified | 2012-12-11 |
| Reported by FDA | 2012-12-19 |
| Terminated | 2015-09-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IN, IR, IS, IT, JP, KR, LT, LV, MX, MY, NL, NO, OM, PH, PL, PT, QA, RO, RS, SA, SE, SI, SK, TH, TR, TW, UY, VN, ZA |
| Quantity | 12,976 |
| Reason classes | potency |
Product
Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The ADVIA Centaur DHEAS assay is an in vitro diagnostic immunoassay for the quantitative determination of dehydroepiandrosterone sulfate (DHEAS) in human serum and plasma using the ADVIA Centaur and ADVIA Centaur XP systems
Reason for recall
Operating range of the ADVIA Centaur systems is 18C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
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-0509-2013. 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.