Access CEA Assay — Class II medical device recall Z-0239-2016
Terminated recall by Beckman Coulter Inc., reported 2015-11-18, distributed nationwide. Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.
| Recall number | Z-0239-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2015-10-13 |
| Classified | 2015-11-06 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2016-04-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BG, BR, CA, CH, CL, CN, CZ, DE, EG, ES, FR, GB, GH, GR, HK, HR, HU, IE, IL, IN, IT, JP, KR, LB, MA, MX, NL, PK, PL, PT, RS, SA, SK, TH, TR, TW, VN, ZA |
| Model numbers | 33200 |
Product
Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
Reason for recall
Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.
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-0239-2016. 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.