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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Louisville Apl Diagnostics Inc
Lot Codes / Batch Numbers
Lot #040531.
Products Sold
Lot #040531.
Louisville Apl Diagnostics Inc is recalling american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE due to Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa.
Recommended Action
Per FDA guidance
Firm notified consignee of recall via phone on 08/10/04. Consignee asked to return conjugates for properly labeled replacements.
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
CT, IN
Page updated: Jan 10, 2026