Abbott Laboratories Diagnostic Div
Aeroset Direct HDL Reagent, LN 7D67-01
| Date | May 9, 2003 (initiated Mar 28, 2003) |
| Status | Terminated |
| Reason | Degredation prior to expiry date. |
| Root cause | Other |
| Action | Firm sent letters on 3/28/2003 requesting laboratories destroy kits that remain for reimbursement. |
| Quantity | 1409 |
| Distribution | Nationwide and to Mexico, Colombia, Canada, Brazil, Ecuador, Hong Kong, New Zealand, Germany, Dominican Republic, El Salvador, Venezuela, Bahamas, Argentina, Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981580 | HDL Abbott Laboratories, Jun 11, 1998 |