Recall Z-1103-2007 ยท MID System, Test, Anticardiolipin Immunological
Louisville Apl Diagnostics Inc
american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE aPL IgM ELISA Kit, Product #649M; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77586.
| Date | Jul 24, 2007 (initiated Aug 10, 2004) |
| Status | Terminated |
| Reason | Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa. |
| Root cause | Other |
| Action | Firm notified consignee of recall via phone on 08/10/04. Consignee asked to return conjugates for properly labeled replacements. |
| Quantity | 35 IgM kits. |
| Distribution | Product distributed to a single direct account in CT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933588 | APHLELISA KIT Louisville Apl Diagnostics, Inc., Oct 13, 1994 |