Z-0034-2008

APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL...

Name: Z-0034-2008 APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL...
Creator: Louisville Apl Diagnostics Inc
Published: 2006-07-18
License: https://open.fda.gov/license/

Louisville Apl Diagnostics Inc / initiated 2006-07-18 / Terminated / root cause: manufacturing process

FDA source

Louisville Apl Diagnostics Inc began a recall of APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in... on 2006-07-18. The reason FDA records is "Product mislabeled; outer container labeled with incorrect lot number". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0034-2008
Status: Terminated
Initiated: 2006-07-18
Posted: 2007-10-04
Terminated: 2007-10-24
Recalling firm: Louisville Apl Diagnostics Inc
Product: APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).
Product code: MID System, Test, Anticardiolipin Immunological
Reason for recall: Product mislabeled; outer container labeled with incorrect lot number.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Firm sent replacement labels to consignee via FedEx on 07/18/06 with instructions for consignee to change the labels on the kit boxes before shipping kits to end users.
Quantity in commerce: 3 test kits (each kit containing 1 IgG and 1 IgM test kit)
Distribution: Product was shipped to a distributor in Canada.
Product codes and lots: Lot #060425. Lot number on the outer packaging of the received kits was 060308.

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)