Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems
FDA device recall Z-1112-2025 · posted 2025-02-05 · Open, Classified
Recall details
- Recalling firm
- Beckman Coulter Inc.
- 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.
- Action taken
- An Urgent Medical Device Recall letter was sent during the week of December 30, 2024, to the affected customers via first class mail and email. If a passing calibration curve can be generated using the Access PCT reagent lots listed above, no action is needed. If repeated calibration failures with a failure code of Max Iterate are obtained using the Access PCT reagent lots listed above, discontinue using the affected reagent lot number.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- PTF
- Quantity affected
- 6,994 US; 10,067 OUS
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Bahrain, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Croatia, Czechia, Denmark, France, Germany, Gre
- Date initiated
- 2025-01-02
- Date posted
- 2025-02-05
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Access PCT, Access PCT Calibrators (K192271) | Beckman Coulter, Inc. | 2019-11-26 |