Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test… — Class II medical device recall Z-0508-2013
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-0508-2013 |
|---|---|
| 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 |
| Reason classes | potency |
Product
Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas.
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
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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.