Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) reader) for use wit
FDA device recall Z-0674-05 · posted 2005-04-06 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- Data reduction Program written for specific sutomated microtiter plate insturment (Bio-Tek ELx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, rather than greater than or equal to 15 U/ml.
- Action taken
- Customers were sent notification letters and effectiveness check form. recommended users manually veify positve results (RSLT), using product insert specifications.
- Root cause
- Other
- Status
- Terminated
- Product code
- MSV
- Quantity affected
- 7
- Distribution
- CT, MI, MT, UT & CANADA
- Date initiated
- 2004-10-26
- Date posted
- 2005-04-06
- Date terminated
- 2006-07-22
- Location
- Stillwater, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY (K982879) | Shield Diagnostics, Ltd. | 1998-10-15 |