ADVIA Centaur CA 19-9 Assay — Class II medical device recall Z-0613-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2016-11-23, distributed nationwide. CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/
| Recall number | Z-0613-2017 |
|---|---|
| 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 | 2016-10-19 |
| Classified | 2016-11-17 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2023-03-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IL, IN, IQ, IT, JO, JP, KR, LT, LV, MT, MX, MY, NI, NL, NP, NZ, PE, PH, PK, PL, PT, PY, RO, RS, SA, SE, SK, TH, TN, TR, TW, UY, VN, ZA |
| Quantity | 30,222 kits |
| Reason classes | potency |
| Expiration dates | 2016-10-21 |
Product
ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491244 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that the assay is being marketed on the XPT following FDAs Reagent Replacement Policy. Siemens plans to request CLIA Categorization for the CA19-9 assay on XPT the week of 11/21/2016.
Reason for recall
CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT systems as stated in the Instructions for Use.
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.