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)
This recall has been terminated (originally issued April 14, 2007).
- Company
- Diasorin Inc.
- Recall Initiated
- February 15, 2007
- Posted
- April 14, 2007
- Terminated
- July 15, 2007
- Recall Number
- Z-0748-2007
- Quantity
- 100 kits
- Firm Location
- Stillwater, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay)
Distribution
Worldwide Distribution --- USA including states of UT, CO, IN, NC, CA, FL and countries of Canada, Spain, Germany, Belgium & Italy.
Lot / Code Info
Part # P2573, Lot 118532
Root 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.
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