Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with use of PRO-Trac Tacrolimus ELISA kit
- Company
- Diasorin Inc.
- Recall Initiated
- April 12, 2004
- Posted
- April 13, 2005
- Terminated
- July 22, 2006
- Recall Number
- Z-0702-05
- Firm Location
- Stillwater, MN
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.
Distribution
CA, Washington DC, FL, KY & Canada
Lot / Code Info
version 12
Root Cause
Other
Action Taken
Customers were sent notification letters and effectiveness check form. recommended users manually veify results using product insert specifications.
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