Access PCT Reagent Pack — Class II medical device recall Z-1112-2025
Ongoing recall by Beckman Coulter Inc., reported 2025-02-12, distributed nationwide. Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate
| Recall number | Z-1112-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2025-01-02 |
| Classified | 2025-02-05 |
| Reported by FDA | 2025-02-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BD, BE, BH, BR, CA, CH, CL, CN, CZ, DE, DK, ES, FR, GB, GR, HR, HU, IE, IN, IT, KR, MX, MY, PE, PH, PL, RO, SK, TH, TN, TR, VN, ZA |
| UPC / GTIN / UDI-DI | 15099590736002 |
| Lot numbers | 339062, 439811 |
| Model numbers | C53987 |
Product
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
Reason for recall
Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time required to achieve a passing calibration curve.
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-1112-2025. 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.