Z-1177-2007

APhL HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distributed by Louisville APL Diagnostics, Inc., Doraville, GA...

Name: Z-1177-2007 APhL HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distributed by Louisville APL Diagnostics, Inc., Doraville, GA...
Creator: Louisville Apl Diagnostics Inc
Published: 2005-10-06
License: https://open.fda.gov/license/

Louisville Apl Diagnostics Inc / initiated 2005-10-06 / Terminated / root cause: labeling and UDI

FDA source

Louisville Apl Diagnostics Inc began a recall of APhL HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360-- Quality Control Fact Sheets for the... on 2005-10-06. The reason FDA records is "Mislabeling: Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits". 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-1177-2007
Status: Terminated
Initiated: 2005-10-06
Posted: 2007-08-17
Terminated: 2007-10-11
Recalling firm: Louisville Apl Diagnostics Inc
Product: APhL HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360-- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. --(current address now in Seabrook, TX 77586).
Product code: MID System, Test, Anticardiolipin Immunological
Reason for recall: Mislabeling: Errors (control values) identified in the QC Fact Sheet for a specific lot of APhL HRP IgG and IgM test kits.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Firm notified consignees of recall via fax on 05/05-06/2005. Consignees asked to replace Quality Control Fact Sheets shipped with test kits with the corrected Quality Control Fact Sheets provided with fax.
Quantity in commerce: 18 IgM test kits.
Distribution: World Wide: Product distributed to direct accounts in CA, FL and GA. Foreign consignees located in Canada and Turkey.
Product codes and lots: Lot #050723

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)