AEROSET System Software version 1.02ER000
FDA device recall Z-0091-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples.
- Action taken
- The firm issued a letter on 09/30/2003 notifying customers of the Device Correction and provided instructions to disable the audible alert. Abbott Diagnostics will correct this issue in the next revision of the AEROSET System Software.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 133
- Distribution
- Nationwide and to the following foreign countries: Norway, United Kingdom, Hong Kong, United Arab Emirates, Canada, New Zealand, and China
- Date initiated
- 2003-09-30
- Date posted
- 2004-07-20
- Date terminated
- 2004-04-07
- 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 |