Z-0823-2016Class II

This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the...

Name: Z-0823-2016 This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the...
Creator: Leica Microsystems, Inc.
Published: 2015-12-30
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2015-12-30 / Terminated / root cause: labeling and UDI

FDA source

Leica Microsystems, Inc. began a recall of This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of... on 2015-12-30. FDA classified it as Class II and gives the reason as "The Bond" Polymer Refine Detection and Novolink" Polymer Detection System may not provide adequate staining when using a detection protocol where one of its components - Peroxide Block / Peroxidase Block is applied...". 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-0823-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-30
Posted: 2016-02-19
Terminated: 2017-01-05
Recalling firm: Leica Microsystems, Inc.
Product: This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: The Bond" Polymer Refine Detection and Novolink" Polymer Detection System may not provide adequate staining when using a detection protocol where one of its components - Peroxide Block / Peroxidase Block is applied after the primary marker incubation as specified in the Instructions for Use Following the Instructions for Use.
Root cause tag: labeling and UDI
FDA root cause: Component change control
Action: The firm sent out a Medical Device Recall letter dated December 29th 2015 to two-hundred (200) consignees in the United States decribing the recall and the neccesary actions to be taken. These included: - Do not use or continue to use the listed antibody with the specified detection kits. - Order replacement detection kits for use with the listed antibody. - There is no need for retrospective review of tissue staining if appropriate positive controls were properly used and interpreted during the immuno / in-situ staining. -pass this notice primarily to the end users where the product has been sold and to all those within your organization who need to be aware of this issue. -Confirm reciept of the Recall Notice letter by signing and dating the attached Acknowledgement Form and faxing it back to us at 1-847-236-3747, or scan and email it to [email protected] Customer are requested to contact their local Leica representative if you have any questions or concerns, or alternatively please contact us at the following email address: [email protected] Peter Lloyd Leica Biosystems Newcastle Ltd Balliol Business Park West Benton Lane Newcastle upon Tyne NE 12 8EW United Kingdom Telephone +44 191 215 0567 Facsimile: +44 191 215 1152
Quantity in commerce: 1700 units
Distribution: US Consignees incluude: AR ,AZ ,CA ,CO ,CT ,DC ,DE ,FL ,GA ,HI ,IA ,IL ,KY ,LA ,MA ,MD ,MI ,MN ,MO ,MT ,NC ,NH ,NJ ,NY ,OH ,OK ,PA ,PR ,SC ,TN ,TX ,UT ,VA ,VT ,WA ,WI and WV. Foreign Consignees include:Argentina , Australia , Brazil , Bulgaria , Chile , China , Ecuador ,Egypt , El Salvador , Finland , France , Georgia , Germany , Greece , India , Italy , Japan , Jordan , Kuwait , Lebanon , Malaysia , Philippines , Poland , Portugal , Romania , Russian Fed. , Singapore , South Korea , Spain , Sweden , Switzerland , Thailand , Tunisia , Turkey , United Kingdom and United Arab Emirates.
Product codes and lots: Product Code/Name: PA0552 (All Lots) Bond Ready-to-Use Primary Antibody PAX-5 (1EW). Detection Kit: DS9800 BondTM Polymer Refine Detection Kit. Affected Detection Kit Lots: 42314, 42388, 42474, 42486, 42499, 42555, 42570, 42579, 42627, 42645, 42683, 42780, 42802, 42823, 42852, 43050.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0823-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0823-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-19

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)