Diasorin Inc. 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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)
Brand
Diasorin Inc.
Lot Codes / Batch Numbers
Part # P2573, Lot 118532
Products Sold
Part # P2573, Lot 118532
Diasorin Inc. is recalling DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitative determin due to Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay). Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay)
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, FL, IN, NC, UT
Page updated: Jan 10, 2026