Aeroset Direct HDL Reagent, LN 7D67-01
FDA device recall Z-0803-03 · posted 2003-05-09 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories Diagnostic Div
- Reason for recall
- Degredation prior to expiry date.
- Action taken
- Firm sent letters on 3/28/2003 requesting laboratories destroy kits that remain for reimbursement.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 1409
- Distribution
- Nationwide and to Mexico, Colombia, Canada, Brazil, Ecuador, Hong Kong, New Zealand, Germany, Dominican Republic, El Salvador, Venezuela, Bahamas, Argentina, Puerto Rico.
- Date initiated
- 2003-03-28
- Date posted
- 2003-05-09
- Date terminated
- 2004-09-16
- Location
- South Pasadena, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HDL (K981580) | Abbott Laboratories | 1998-06-11 |