Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials
This recall has been terminated (originally issued July 20, 2004).
- Recall Initiated
- March 1, 2004
- Posted
- July 20, 2004
- Terminated
- August 19, 2004
- Recall Number
- Z-0773-04
- Quantity
- 77886 vials
- Firm Location
- Newark, DE
- Official Source
- View on FDA website ↗
Reason for Recall
cloudy appearance or precipitate
Distribution
The products were shipped to one diagnostic facility in PA. The products were also shipped to Germany, Poland, Spain, France, Italy, Portugal, Mexico, Thailand, and Uruguay.
Lot / Code Info
Lot numbers 523785, 523785A, 523785B, and 523787
Root Cause
Other
Action Taken
The recalling firm issued recall letters dated 3/4/04 to their direct accounts informing them of the problem and what to do if a vial is found to be cloudy.
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