AEROSET Software versions 1.00ER005, catalog number 2-89996-01 and 1.00ER005.2, catalog number 2-89996-02
FDA device recall Z-0725-03 · posted 2003-04-16 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- Under certain operating conditions, smart wash feature disables with multiple samples.
- Action taken
- A device correction letter was sent 02/24/2003 to all AEROSET customers with a US Customer Reply Form. A Technical Service Bulletin will be released to include the Device Correction letter and instructions for Field Service Personnel. A Quality Directive will be issued to provide instructions to Customer Service.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 645 units
- Distribution
- Nationwide and to Mexico, Guatemala, Venezuela, Columbia, Argentina, Brazil, Puerto Rico, Dominican Republic, Canada, Germany, Hong Kong, Australia, and New Zeland
- Date initiated
- 2003-02-24
- Date posted
- 2003-04-16
- Date terminated
- 2004-10-28
- 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 |