BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
FDA device recall Z-1370-2015 · posted 2015-06-26 · Terminated
Recall details
- Recalling firm
- BD Biosciences, Systems & Reagents
- Reason for recall
- The circuit breakers on some BD FACSCalibur instruments may have the incorrect rated amperage (20 amps instead of 2 amps) causing the circuit breaker to fail to open in an over-current situation.
- Action taken
- BD Biosciences sent an Important Product Recall letter on March 6, 2015 by certified mail and Field Change Notification (FCN FCB15-01-660312 directing Field Service Engineers to correct the circuit breaker is in process. Customers with questions were instruct to contact BD Customer Support at 1-877-232-8995 (prompt 2) in the United States. For customers outside the US were instructed to contact their local BD Biosciences representative or distributor. For questions regarding this recall call 408-954-6080.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- OYE
- Quantity affected
- 72 devices
- Distribution
- Worldwide Distribution -US including TX, NJ, and OK and Internationally to Hong Kong, Japan, Singopore, and Belguim
- Date initiated
- 2015-03-06
- Date posted
- 2015-06-26
- Date terminated
- 2016-04-04
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION (K980858) | Becton Dickinson Immunocytometry Systems | 1998-05-22 |