Recall Z-1175-2007 ยท MID System, Test, Anticardiolipin Immunological
Louisville Apl Diagnostics Inc
APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. (address now in Seabrook, TX 77586).
| Date | Aug 17, 2007 (initiated Oct 6, 2005) |
| Status | Terminated |
| Reason | Mislabeing : Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits. |
| Root cause | Other |
| Action | Firm notified consignees of recall via fax on 05/05-06/2005. Consignees asked to replace Quality Control Fact Sheets shipped with test kits with the corrected Quality Control Fact Sheets provided with fax. |
| Quantity | 29 test kits (ea. kit containing 1 IgG and 1 IgM test kit) |
| Distribution | World Wide: Product distributed to direct accounts in CA, FL and GA. Foreign consignees located in Canada and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933588 | APHLELISA KIT Louisville Apl Diagnostics, Inc., Oct 13, 1994 |