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).
FDA Recall Z-0034-2008 · Posted 2007-10-04
Recalling FirmLouisville Apl Diagnostics Inc
Recall StatusTerminated
Product CodeMID
Date Initiated2006-07-18
Date Terminated2007-10-24
Product Quantity3 test kits (each kit containing 1 IgG and 1 IgM test kit)
Reason for Recall
Product mislabeled; outer container labeled with incorrect lot number.
Firm 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.
Root Cause
Process design
Distribution Pattern
Product was shipped to a distributor in Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.