BioTek brand Automated Microplate Reader; model ELx808, Roche catalog number 03145387001.
FDA device recall Z-0574-05 · posted 2005-03-08 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- The parameters loaded in the analyzer for the hepatitis C virus do not match those in the package insert, and patient results may be reported out as false positives or false negatives.
- Action taken
- Recall letters dated 2/15/05 are being sent to each consignee instructing them to discontinue use of pre-programmed HCV parameters with the Amplicor heatitis C virus test and that previous test results within a specific range be reviewed by a physician.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJQ
- Distribution
- Nationwide and Canada.
- Date initiated
- 2005-02-15
- Date posted
- 2005-03-08
- Date terminated
- 2006-05-10
- Location
- Indianapolis, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELX808 AUTOMATED MICROPLATE READERS (K953710) | Bio-Tek Instruments, Inc. | 1995-10-25 |