ARCHITECT Processing Module, List number 8C89-01, manufactured by Abbott Laboratories, Irving, Texas
FDA device recall Z-1133-03 · posted 2003-08-13 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- Under specific conditions, the system can allow an incorrect sample ID to be assigned to another sample in a different carrier.
- Action taken
- Technical Service Bulletin 114-041 was sent to the Abbott Laboratories Field Service Organization with instructions to correct all ARCHITECT i 2000 systems worldwide.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 787
- Distribution
- Nationwide and to the following foreign countries: Canada, Mexico, Venezuela, Chile, Brazil, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, Korea, Australia, New Zealand.
- Date initiated
- 2001-12-10
- Date posted
- 2003-08-13
- Date terminated
- 2003-08-12
- 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 |
|---|---|---|
| ABBOTT ARCHITECT TESTOSTERONE (K983212) | Abbott Laboratories | 1998-11-18 |