Z-3182-2011

Leica Bond Ready-to-Use Primary Antibody Epithelial Membrane Antigen (GP1.4); an in vitro diagnostic...

Name: Z-3182-2011 Leica Bond Ready-to-Use Primary Antibody Epithelial Membrane Antigen (GP1.4); an in vitro diagnostic...
Creator: Leica Microsystems, Inc.
Published: 2011-07-26
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2011-07-26 / Terminated / root cause: manufacturing process

FDA source

Leica Microsystems, Inc. began a recall of Leica Bond Ready-to-Use Primary Antibody Epithelial Membrane Antigen (GP1.4); an in vitro diagnostic immunohistochemistry primary antibody kit; Catalog No... on 2011-07-26. The reason FDA records is "There was an issue with the controlled temperature storage unit where the products were stored prior to shipment to the customers". 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-3182-2011
Status: Terminated
Initiated: 2011-07-26
Posted: 2011-09-09
Terminated: 2011-09-09
Recalling firm: Leica Microsystems, Inc.
Product: Leica Bond Ready-to-Use Primary Antibody Epithelial Membrane Antigen (GP1.4); an in vitro diagnostic immunohistochemistry primary antibody kit; Catalog No. PA0035; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. Epithelial Membrane Antigen (GP1.4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human epithelial membrane antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond-max system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: There was an issue with the controlled temperature storage unit where the products were stored prior to shipment to the customers.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Leica Microsystems, Inc. notified all affected customers by telephone on July 26, 2011. The product, problem, and actions to be taken by the customers were discussed. Customers were instructed to discontinue use of the product and to return the product. All affected product has been returned to the firm.
Quantity in commerce: 3 units
Distribution: Nationwide Distribution-in the states of Indiana and Kentucky.
Product codes and lots: Catalog number PA0035, lot number 13622

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)