ARCHITECT Processing Module, manufactured by Abbott Laboratories, Irving, Texas
FDA device recall Z-0172-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- If the interlock cable connected to the door lid sensor is disconnected or fails, the lid is detected as closed even though it may be open.
- Action taken
- Firm sent technical service bulletins with corrective instructions to consignees with all existing ARCHITECT i 2000 processing modules in February 2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 1,167 units worldwide
- Distribution
- States of Virginia, Illinois, New York, Texas, Oklahoma, Pennsylvania, ILlinois, Michigan, California, New Hampshire, Ohio, Florida, Maryland, Nevada, Georgia, Minnesota, Colorado, Arizona, Missouri,
- Date initiated
- 2002-05-08
- Date posted
- 2004-07-20
- Date terminated
- 2003-11-26
- 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 |