Access 2 Immunoassay Analyzer — Class II medical device recall Z-1386-2025
Ongoing recall by Beckman Coulter, Inc., reported 2025-03-26, distributed nationwide. Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causin
| Recall number | Z-1386-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2025-02-05 |
| Classified | 2025-03-17 |
| Reported by FDA | 2025-03-26 |
| Distributed | Nationwide (US) |
| Quantity | 873 units |
| UPC / GTIN / UDI-DI | 15099590265380 |
| Serial numbers | 502304, 508626, 509167, 510520, 510973, 511125, 511429, 511650, 511948, 511951, 512247, 570386, 570465, 570759, 570853, 571175, 571450, 571672, 572801, 572934, 573058, 573072, 573073, 573109, 573130 and 475 more |
| Model numbers | 81600N |
Product
Access 2 Immunoassay Analyzer, Catalog Number 81600N
Reason for recall
Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test 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-1386-2025. 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.