Aeroset Analyzer, item 9D05-01
FDA device recall Z-0843-03 · posted 2003-05-20 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- Extensive use of cuvettes causes inaccurate results. Preventative maintenance did not specify replacement schedule.
- Action taken
- The firm issued a letter to affected consignees on or about 10/02/2001 notifying the consignees that an Abbott Field Representative will perform a one-time cuvette upgrade to the consignee''s AEROSET system.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 238 units
- Distribution
- Nationwide and to the following foreign countries: Mexico, Guatemala, Venezuela, Columbia, Argentina, Brazil, Dominican Republic, Canada, Germany, Hong Kong, Australia, New Zealand, China, England
- Date initiated
- 2001-10-02
- Date posted
- 2003-05-20
- 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 |