american diagnostica inc. IgG Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE aPL IgG ELISA Kit, Product #649G; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77586.
FDA Recall Z-1104-2007 · Posted 2007-07-24
Recalling FirmLouisville Apl Diagnostics Inc
Recall StatusTerminated
Product CodeMID
Date Initiated2004-08-10
Date Terminated2007-11-27
Product Quantity45
Reason for Recall
Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa.
Firm Action
Firm notified consignee of recall via phone on 08/10/04. Consignee asked to return conjugates for properly labeled replacements.
Root Cause
Other
Distribution Pattern
Product distributed to a single direct account in CT.
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.