Pentra 80 and Pentra 80XL Hematology Analyzers
FDA device recall Z-0298-06 · posted 2005-12-23 · Terminated
Recall details
- Recalling firm
- ABX Diagnostics Inc
- Reason for recall
- Software defect, instrument may erroneously give a result of '0' or '---'.
- Action taken
- Firm sent a notification/recall letter on April 8, 2004. They plan to modify the software in August 2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 67
- Distribution
- Nationwide.
- Date initiated
- 2004-04-08
- Date posted
- 2005-12-23
- Date terminated
- 2006-02-06
- Location
- Irvine, CA
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