AEROSET Analyzer System, Model 9D05-01, distributed by Abbott Laboratories Diagnostic Division, Irving, Texas
FDA device recall Z-0846-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- Change of level 3 error log messages to level 1 to prevent suspect assay results.
- Action taken
- The recall was initiated by letter on March 22, 2004. The letter instructed customers regarding steps to change the error levels on each AEROSET system.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 656
- Distribution
- Nationwide and to the following foreign countries: Mexico, Columbia, Puerto Rico, Germany, New Zealand, Guatemala, Argentina, Dominican Republic, Hong Kong, Romania, Venezuela, Brazil, Canada, Austral
- Date initiated
- 2004-03-22
- Date posted
- 2004-07-20
- Date terminated
- 2007-04-13
- 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 |