Z-0748-2007

DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitative determination of...

Name: Z-0748-2007 DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitative determination of...
Creator: Diasorin Inc.
Published: 2007-02-15
License: https://open.fda.gov/license/

Diasorin Inc. / initiated 2007-02-15 / Terminated

FDA source

Diasorin Inc. began a recall of DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitative determination of trypsin-like immunoreactiviy (TLI) in human serum... on 2007-02-15. The reason FDA records is "Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0748-2007
Status: Terminated
Initiated: 2007-02-15
Posted: 2007-04-14
Terminated: 2007-07-15
Recalling firm: Diasorin Inc.
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)
Product code: JNO N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
Reason for recall: Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay)
FDA 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 in commerce: 100 kits
Distribution: Worldwide Distribution --- USA including states of UT, CO, IN, NC, CA, FL and countries of Canada, Spain, Germany, Belgium & Italy.
Product codes and lots: Part # P2573, Lot 118532

Product code JNO

K791202Class IRia Kit for TrypsinCis Radiopharmaceuticals, Inc. / cleared 1979-11-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)