COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and 1A2. The LH 500 Ana
FDA device recall Z-1433-04 · posted 2004-09-02 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Beckman Coulter has confirmed an issue associated with the predilute mode of the COULTER LH 500 Hematology Analyzer. The workstation may display, transmit, and / or print an erroneous result or an incorrect dilution factor with a predilute sample result.
- Action taken
- Customers were notified via U.S. mail by a Product Corrective Action Letter (PCA) dated August 12, 2004. The letter includes a description of what conditions need to be met for the error to occur and the proper steps to prevent the issue from occurring.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 222
- Distribution
- Nationwide & Canada
- Date initiated
- 2004-08-12
- Date posted
- 2004-09-02
- Date terminated
- 2012-04-26
- 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 |