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Terminated

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.

FDA Recall Z-1103-2007 · Posted 2007-07-24

Recalling FirmLouisville Apl Diagnostics Inc
Recall StatusTerminated
Product CodeMID
Date Initiated2004-08-10
Date Terminated2007-11-27
Product Quantity35 IgM kits.

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.

K933588APHLELISA KITLouisville Apl Diagnostics, Inc. · 1994-10-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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