Version 7 Software for wash program on Bio Tek Automated Microplate Washer Model ELx50 which performs the washing steps
FDA device recall Z-0703-05 · posted 2005-04-13 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- When software was updated for the Washer program of the Bio Tek Automated Microplate Washer Model ELx50, the software did not automatically clear old versions of the wash program when new ones were added.
- Action taken
- Customers were notified by phone and informed of the problem and recommended users to use only the newer wash program which is identified is a 'W' in front of the program.
- Root cause
- Other
- Status
- Terminated
- Product code
- JTC
- Quantity affected
- 9
- Distribution
- CA, FL, NH, PA, SD, TX, WA
- Date initiated
- 2004-05-20
- Date posted
- 2005-04-13
- 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 |
|---|---|---|
| BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403 (K884125) | Bio-Tek Instruments, Inc. | 1988-12-02 |