FDA Recall
Terminated
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)
Recall: Z-0748-2007
·
Initiated February 15, 2007
Recall
- Recall Number
- Z-0748-2007
- Event Number
- 37606
- Firm
- Diasorin Inc.
- FEI Number
- 2182595
- Product Code
- JNO
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 15, 2007
- Posted
- April 14, 2007
- Terminated
- July 15, 2007
- Address
- 1951 Northwestern Ave S, Stillwater, MN, 55082-7536
Description
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)
Reason
Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay)
Action
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.
Distribution
Worldwide Distribution --- USA including states of UT, CO, IN, NC, CA, FL and countries of Canada, Spain, Germany, Belgium & Italy.
Quantity
100 kits