Z-1103-2007

american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE aPL IgM...

Name: Z-1103-2007 american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE aPL IgM...
Creator: Louisville Apl Diagnostics Inc
Published: 2004-08-10
License: https://open.fda.gov/license/

Louisville Apl Diagnostics Inc / initiated 2004-08-10 / Terminated / root cause: labeling and UDI

FDA source

Louisville Apl Diagnostics Inc began a recall of american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE aPL IgM ELISA Kit, Product #649M; manufactured by... on 2004-08-10. The reason FDA records is "Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1103-2007
Status: Terminated
Initiated: 2004-08-10
Posted: 2007-07-24
Terminated: 2007-11-27
Recalling firm: Louisville Apl Diagnostics Inc
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.
Product code: MID System, Test, Anticardiolipin Immunological
Reason for recall: Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Firm notified consignee of recall via phone on 08/10/04. Consignee asked to return conjugates for properly labeled replacements.
Quantity in commerce: 35 IgM kits.
Distribution: Product distributed to a single direct account in CT.
Product codes and lots: Lot #040531.

Product code MID

K933588Class IIAphlelisa KitLouisville Apl Diagnostics, Inc. / cleared 1994-10-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)