Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.
This recall has been terminated (originally issued February 15, 2005).
- Recall Initiated
- December 3, 2004
- Posted
- February 15, 2005
- Terminated
- October 18, 2005
- Recall Number
- Z-0538-05
- Quantity
- 25381 units
- Firm Location
- Newark, DE
- Official Source
- View on FDA website ↗
Reason for Recall
decrease in product stability after reconstitution and reduced stability on board certain instrument systems
Distribution
The product was shipped nationwide to medical facilities.
Lot / Code Info
Lot numbers 544531 to 544548 and 544502 to 544504.
Root Cause
Other
Action Taken
The recalling firm issued a recall letter to their customers informing them of the problem and the need to use internal quality controls with the analyzers. The letter instructed customer to discard lot # 544545 and reduce the stability for the other lot numbers involved.
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