Coulter LH500 Hematology Analyzer: Part Numbers 178832, 178833, 178834
FDA device recall Z-1245-06 · posted 2006-07-18 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Beckman has confirmed that erroneous results could be reported when the workstation database crashes.
- Action taken
- A Product Corrective Action (PCA) letter was sent week of April 17, 2006 via US mail. The letter outlines action to be taken to avoid potential erroneous results. Firm targeting 75% effectivenss checks.
- Root cause
- Other
- Status
- Terminated
- Product code
- LOQ
- Quantity affected
- 759
- Distribution
- Nationwide and Canada
- Date initiated
- 2006-04-17
- Date posted
- 2006-07-18
- Date terminated
- 2012-04-19
- 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 |
|---|---|---|
| COULTER LH 500 HEMATOLOGY ANALYZER (K032000) | Beckman Coulter, Inc. | 2003-08-13 |