Coulter AcT 5diff Autoloader (AL) Hematology Analyzer
FDA device recall Z-0987-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Software anomaly causes sample results to be not credible, reported as '0' or left blank. The next sample will also be incorrectly reported for the same parameter.
- Action taken
- Firm sent recall letter on or about April 20, 2004 informing users of the issue. Firm will implement a software solution in the near future.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 70
- Distribution
- Nationwide and Canada
- Date initiated
- 2004-04-20
- Date posted
- 2004-07-20
- Date terminated
- 2005-09-02
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COULTER ACT 5DIFF AUTOLOADER (AL) (K030291) | Beckman Coulter, Inc. | 2003-04-17 |