Recall Z-0702-05 ยท MLM Enzyme Immunoassay, Tracrolimus
Diasorin Inc.
Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with use of PRO-Trac Tacrolimus ELISA kit
| Date | Apr 13, 2005 (initiated Apr 12, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Customers were sent notification letters and effectiveness check form. recommended users manually veify results using product insert specifications. |
| Distribution | CA, Washington DC, FL, KY & Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.