Recall Z-0675-05 ยท JZO System, Test, Thyroid Autoantibody
Diasorin Inc.
Data reduction program software written specifically for Bio-Tek ELx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700).
| Date | Apr 6, 2005 (initiated Apr 12, 2004) |
| Status | Terminated |
| Reason | The data reduction program written for a specific automated microtiter plate reader (Bio-Tek ELx800) was found to be faulty. This program is used to calculate the cut off values for the Diastat Anti-Thyroglobulin Kit assay. The negative Control Upper Limit should be less than 0.95, rather than less than 1.0. |
| Root cause | Other |
| Action | Customers were sent a notification letter directing customers to check historical data for negative control results reading greater than 0.95 but less than 1.0. These results are invalid and patient results should not have been reported. Customers are instructed to verify negative control manually until new software version is installed. An effectiveness check form is requested to be returned. |
| Quantity | 6 |
| Distribution | CA, FL, MA, NY & TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952183 | DIASTAT ANTI-THYROGLOBULIN KIT Shield Diagnostics, Ltd., Jun 30, 1995 |