Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 reader for use with the ENA 6 Scre
FDA device recall Z-0672-05 · posted 2005-04-06 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- An error in the Bio-Tek ELx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing.
- Action taken
- Customers were sent a notification letter informing customers of an error in the Bio-Tek ELx800 programming specifications. Customers were asked to repeat testing for historical runs for RSLT (S/CO) that read from 0.95 to 1.0. A response form is asked to be faxed back to DiaSorin.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLL
- Quantity affected
- 29
- Distribution
- CT, FL, NY, WA, TX, AR, TN, CANADA
- Date initiated
- 2004-04-20
- 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 |
|---|---|---|
| DIASTAT ENA SINGLE WELL SCREEN KIT (K944505) | Shield Diagnostics, Ltd. | 1994-11-21 |