Recall Z-0748-2007 ยท JNO N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
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)
| Date | Apr 14, 2007 (initiated Feb 15, 2007) |
| Status | Terminated |
| Reason | Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay) |
| Root cause | Other |
| 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. |
| Quantity | 100 kits |
| Distribution | Worldwide Distribution --- USA including states of UT, CO, IN, NC, CA, FL and countries of Canada, Spain, Germany, Belgium & Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K791202 | RIA KIT FOR TRYPSIN Cis Radiopharmaceuticals, Inc., Nov 5, 1979 |