COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 660
FDA device recall Z-0475-06 · posted 2006-02-04 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- There is a risk of sample misidentification when processing samples in the Manual aspiration mode.
- Action taken
- A Product Corrective Action letter will be mailed the week of Dec 19, 2005 to all COUL TER@ LH700 Series System & COUL TER@ GEN.STM System customers instructing them of a rare risk of sample misidentification. (Letter will be sent by US mail)
- Root cause
- Other
- Status
- Terminated
- Product code
- GKJ
- Quantity affected
- 1134
- Distribution
- Nationwide and Canada
- Date initiated
- 2005-12-15
- Date posted
- 2006-02-04
- Date terminated
- 2012-01-26
- 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 GEN-S SYSTEM (K962988) | Coulter Corp. | 1996-10-30 |