ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
FDA device recall Z-0008-06 · posted 2005-10-06 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- Device has incorrect notation associated with therapeutic drug monitoring assays.
- Action taken
- Firm sent device correction letters to consignees on 2/28/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 1,107 units worldwide
- Distribution
- California, Louisiana, Massachusetts, North Carolina, Missouri, Oklahoma, Texas, Illinois, Minnesota, South Dakota, North Dakota and Arizona. Foreign countries: Mexico, Columbia, Chile, Canada, German
- Date initiated
- 2005-02-28
- Date posted
- 2005-10-06
- Date terminated
- 2005-11-03
- Location
- Irving, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AEROSET SYSTEM (K980367) | Abbott Laboratories | 1998-04-01 |