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). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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).
Brand
Louisville Apl Diagnostics Inc
Lot Codes / Batch Numbers
Lot #060425. Lot number on the outer packaging of the received kits was 060308.
Products Sold
Lot #060425. Lot number on the outer packaging of the received kits was 060308.
Louisville Apl Diagnostics Inc is recalling APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville due to Product mislabeled; outer container labeled with incorrect lot number.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product mislabeled; outer container labeled with incorrect lot number.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026