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)
FDA Recall Z-0748-2007 · Posted 2007-04-14
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Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeJNO
Date Initiated2007-02-15
Date Terminated2007-07-15
Product Quantity100 kits
Reason for Recall
Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay)
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide Distribution --- USA including states of UT, CO, IN, NC, CA, FL and countries of Canada, Spain, Germany, Belgium & Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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