BC Thrombin Reagent . Thrombin Time Test
This recall has been terminated (originally issued October 5, 2004).
- Recall Initiated
- July 21, 2004
- Posted
- October 5, 2004
- Terminated
- December 15, 2004
- Recall Number
- Z-0007-05
- Quantity
- 3942 kits
- Firm Location
- Newark, DE
- Official Source
- View on FDA website ↗
Reason for Recall
The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin
Distribution
The products were shipped to medical facilities in CT, FL, IA, IL, NJ, PA, and WI. The products were also shipped to Austria, Bosnia, Croatia, Hungry, Germany, Poland, Spain, RussiaFrance, Italy, Australia, Brazil, Canada, Saudi Arabia, El Salvador, and Turkey.
Lot / Code Info
Lot 540624, Lot 540625, and Lot 540626
Root Cause
Other
Action Taken
The recalling firm issued a recall letter dated 7/21/04 to their accounts informing them of the problem and the need to discard the product.
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