Official recall record
Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-01-02
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 15099590736002
- Brand on record
- Beckman Coulter Inc.
- Product category
- Medical Device
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-09-02 · US FDA — Medical Devices
DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU - 2026-09-02 · US FDA — Medical Devices
DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520 - 2026-07-15 · US FDA — Medical Devices
Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Modul
All 32 official recall notices naming Beckman Coulter, Inc. on this site →
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