Data reduction program software written specifically for Bio-Tek ELx800 (DiaSorin part # 15713) automated microtiter pla
FDA device recall Z-0675-05 · posted 2005-04-06 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JZO
- Quantity affected
- 6
- Distribution
- CA, FL, MA, NY & TX
- Date initiated
- 2004-04-12
- Date posted
- 2005-04-06
- Date terminated
- 2006-07-22
- Location
- Stillwater, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIASTAT ANTI-THYROGLOBULIN KIT (K952183) | Shield Diagnostics, Ltd. | 1995-06-30 |