BECKMAN COULTER ACCESS Immunoassay Systems — Class II medical device recall Z-3006-2020
Terminated recall by Beckman Coulter Inc., reported 2020-09-30, distributed nationwide. Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol a
| Recall number | Z-3006-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2020-08-26 |
| Classified | 2020-09-24 |
| Reported by FDA | 2020-09-30 |
| Terminated | 2024-05-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BR, CA, CN, CZ, DE, GB, HU, IE, IN, IT, JO, KR, LB, MX, MY, NP, PA, PK, PT, RS, RU, SA, SK, TH, TR, TW, VN, ZA |
| Quantity | 21,455 assay |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 15099590231187 |
| Lot numbers | 921133, 921348, 921742 |
| Model numbers | 33570 |
Product
BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
Reason for recall
Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.
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-3006-2020. 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.