AEROSET Analyzer, Systems Operation Manual.
FDA device recall Z-0016-05 · posted 2004-10-09 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- Changes to the printer default settings made by users/operators cause printed data to be truncated and misidentified.
- Action taken
- The recall was initiated by Device Correction Letter to all AEROSET customers. The Device Correction Letter will be provided to new customers until the new revision of the Operations Manual.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 835 units
- Distribution
- Nationwide and to: Mexico, Columbia, Puerto Rico, Germany, New Zealand, Guatemala, Argentina, Dominican Republic, Hong Kong, Romania, Venezuela, Brazil, Canada, and Australia
- Date initiated
- 2004-09-24
- Date posted
- 2004-10-09
- 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 |