Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Ant
FDA device recall Z-0673-05 · 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 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DBM
- Quantity affected
- 8
- Distribution
- CA, CT, KS, MA & WA
- 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-MITOCHONDRIAL ANTIBODY KIT (K921183) | Shield Diagnostics, Ltd. | 1992-06-19 |