Recall Z-0673-05 ยท DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Diasorin Inc.
Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit
| Date | Apr 6, 2005 (initiated Apr 12, 2004) |
| Status | Terminated |
| Reason | The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800 reader) was found to be faulty. This program is used to calculate the cut off values for Diastat Anti-Mitochondrial Antibody Kit. Program should include a borderline specification to indicate repeat testing is needed. |
| Root cause | Other |
| Action | A notification letter and effectiveness check form was sent to consignees. This letter recommended that users manually verify results using the specifications outlined in the package insert until a new software version is installed. |
| Quantity | 8 |
| Distribution | CA, CT, KS, MA & WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K921183 | DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT Shield Diagnostics, Ltd., Jun 19, 1992 |