CELL-DYN Sapphire Hematology Analyzer, List numbers 08H00-01, 08H00-03 A multi- parameter, automated hematology analyzer
FDA device recall Z-0306-2009 · posted 2008-11-21 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories
- Reason for recall
- Exposed wire resulted in minor electrical shock and burn to the service technician
- Action taken
- Recall issued August 22, 2008. Technical service bulletin was issued for all field personnel via internal database. No customer communication is planned as customers are instructed *not* to remove the cover, which is necessary to access the area.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 958 units
- Distribution
- Worldwide Distribution --- including USA and countries of Argentina, Australia, Brazil, Canada, Chile, China WFOTC, Colombia, Germany, Hong Kong, Japan, Mexico, New Zealand, Panama, Paraguay, Peru, Si
- Date initiated
- 2008-08-25
- Date posted
- 2008-11-21
- Date terminated
- 2011-01-06
- Location
- Santa Clara, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELL-DYN SAPPHIRE SYSTEM (K051215) | Abbott Laboratories | 2005-07-21 |