BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains the Syphilis IgG Ass
FDA device recall Z-0256-2008 · posted 2007-11-09 · Terminated
Recall details
- Recalling firm
- Bio-Rad Labroatories Inc.
- Reason for recall
- Mislabeling: Reporting terminology in the Syphilis IgG APF CD is not consistent with the distributed Instructions for Use. (Non-Reactive and Reactive rather than Negative and Positive)
- Action taken
- The recalling firm notified consignees by phone call on 9/25/2007, followed up with a fax notification. The firm plans to monitor the consignees that do not respond by tracking on a spreadsheet and following up with another phone call. Consignees are instructed to destroy the APF CD which will be replaced at a later date.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- LIP
- Quantity affected
- 36
- Distribution
- Nationwide
- Date initiated
- 2007-09-25
- Date posted
- 2007-11-09
- Date terminated
- 2008-04-16
- Location
- Hercules, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOPLEX 2200 SYPHILIS IGG KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K063866) | Bio-Rad Laboratories | 2007-03-19 |