Recall Z-0034-2008 ยท MID System, Test, Anticardiolipin Immunological
Louisville Apl Diagnostics Inc
APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).
| Date | Oct 4, 2007 (initiated Jul 18, 2006) |
| Status | Terminated |
| Reason | Product mislabeled; outer container labeled with incorrect lot number. |
| Root cause | Process design |
| Action | Firm sent replacement labels to consignee via FedEx on 07/18/06 with instructions for consignee to change the labels on the kit boxes before shipping kits to end users. |
| Quantity | 3 test kits (each kit containing 1 IgG and 1 IgM test kit) |
| Distribution | Product was shipped to a distributor in Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933588 | APHLELISA KIT Louisville Apl Diagnostics, Inc., Oct 13, 1994 |