ADVIA Centaur CA 125II Assay — Class II medical device recall Z-1486-2018
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2018-05-02, distributed nationwide. Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the
| Recall number | Z-1486-2018 |
|---|---|
| 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 | 2018-02-21 |
| Classified | 2018-04-24 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2019-05-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KR, LK, LT, LU, LV, MA, MT, MX, MY, NI, NL, NO, NP, NZ, PE, PH, PK, PL, PT, PY, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, UA, UY, VN, ZA |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 00630414461298, 00630414461304 |
| Lot numbers | 2018-APR-27, 2018-AUG-30, 23903176, 23904176, 24439176, 24944176, 31842176, 41442176, 42051176, 46735176, 54008176, 71229174, 71804174, 73455174, 73838174, 84113174, 88601174, 91568174, 94549174 |
| Model numbers | 01678114, 09427226, 10310443, 10315696 |
Product
ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
Reason for recall
Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
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-1486-2018. 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.