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). 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; 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).
Brand
Louisville Apl Diagnostics Inc
Lot Codes / Batch Numbers
Lot #050723
Products Sold
Lot #050723
Louisville Apl Diagnostics Inc is recalling APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; distributed by Louisville APL Diagnostics, Inc. due to Mislabeing : Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeing : Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.
Recommended Action
Per FDA guidance
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.
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
CA, FL, GA, IN
Page updated: Jan 10, 2026