Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with use of PRO-Trac Tacrol
FDA device recall Z-0702-05 · posted 2005-04-13 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- 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.
- Action taken
- Customers were sent notification letters and effectiveness check form. recommended users manually veify results using product insert specifications.
- Root cause
- Other
- Status
- Terminated
- Product code
- MLM
- Distribution
- CA, Washington DC, FL, KY & Canada
- Date initiated
- 2004-04-12
- Date posted
- 2005-04-13
- Date terminated
- 2006-07-22
- Location
- Stillwater, MN
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