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Terminated

Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with use of PRO-Trac Tacrolimus ELISA kit

FDA Recall Z-0702-05 · Posted 2005-04-13

Recalling FirmDiasorin Inc.
Recall StatusTerminated
Product CodeMLM
Date Initiated2004-04-12
Date Terminated2006-07-22

Reason for Recall

The software program written for use in the automated microtiter plate reader (Bio-Tek ELx800) for use with the Pro-Trac II Tacrolimus ELISA kit was found to be faulty. Assay software program did not include the Calibrator Zero OD specification (STDO>=1.500) as specified in the product insert.

Firm Action

Customers were sent notification letters and effectiveness check form. recommended users manually veify results using product insert specifications.

Root Cause

Other

Distribution Pattern

CA, Washington DC, FL, KY & Canada

Official Source

View FDA Recall →

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

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