Dade Fibrin(ogen) Degradation Products (FDP) Detection Set. Catalog number B4233-10E
- Company
- Dade Behring Inc.
- Recall Initiated
- June 21, 2005
- Posted
- July 22, 2005
- Terminated
- May 1, 2006
- Recall Number
- Z-1040-05
- Quantity
- 364 kits
- Firm Location
- Newark, DE
Reason for Recall
positive control shows weak agglutination reaction
Distribution
The product was shipped to hospital laboratories nationwide. The product was also shipped to Hungary, Switzerland, Poland, Spain, Italy, Argentina, Columbia, Mexico, Panama, Phillipines, El Salvadore, and Taiwan.
Lot / Code Info
Lot number P152010 exp 4/30/06.
Root Cause
Other
Action Taken
The recalling firm notified their customers on 6/21/05 via letter dated 6/17/05. The customers were instructed to discontinue the use of the affected lot and discard any remaining inventory.
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