Recall Z-0748-2007
Diasorin Inc. · initiated February 15, 2007
Product
DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitative determination of trypsin-like immunoreactiviy (TLI) in human serum or plasma samples)
Codes / lots: Part # P2573, Lot 118532
Reason for recall
Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay)
FDA-determined cause: Other
Action taken
The consignees & distributors were notified by letter on 2/15/07 . The Distributors are instructed to forward the notification to the customers who have received the affected products. A response form will be requested from the customers.
Details
- Recall number
- Z-0748-2007
- Initiated
- February 15, 2007
- Posted by FDA
- April 14, 2007
- Terminated
- July 15, 2007
- Product code
- JNO – N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
- Quantity
- 100 kits
- Distribution
- Worldwide Distribution --- USA including states of UT, CO, IN, NC, CA, FL and countries of Canada, Spain, Germany, Belgium & Italy.
- Recalling firm
- Diasorin Inc., Stillwater, MN