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Terminated

DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C

FDA Recall Z-0658-05 · Posted 2005-03-29

Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeLSE
Date Initiated2004-11-01
Date Terminated2006-07-22
Product Quantity46

Reason for Recall

The DiaSorin ETI-EA-G kits contained the wrong microtiter plate. The plate provided in the kits was for a different product, the ProTrac II Tacrolimus kit.

Firm Action

Customers were notified of the product and problem via telephone and instructed to check any remaining inventory and discard all incorrect plates. Replacement plates were offered.

Root Cause

Other

Distribution Pattern

FL, TX & UT

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992191ETI-EA-G ASSAYDiaSorin, Inc. · 1999-07-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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