BD Unopette -- System Tests (Erythrocyte Fragility Test Kit). Catalog # 365830, Exp Date 2006-06, Manufactured by BD in
FDA device recall Z-1446-06 · posted 2006-08-26 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- Formulation problems-lower pH of the solutions may increase Red Blood Cell hemolysis
- Action taken
- Recall letters were sent via first class mail on 7/11/2005 by US mail, return receipt requested. A second notification was sent 8/4/2005
- Root cause
- Other
- Status
- Terminated
- Product code
- GKE
- Quantity affected
- Lot # 5014328 - 1,980 kits; Lot 5159075 - 4,360 kits
- Distribution
- World wide-USA, Canada, Europe, Asia Pacific.
- Date initiated
- 2005-06-01
- Date posted
- 2006-08-26
- Date terminated
- 2006-08-25
- Location
- Franklin Lakes, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.