Leica Microsystems, Inc.: 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.

Recall number

Z-0823-2016

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.

Status

Terminated

Initiated

2015-12-30

Posted

2016-02-19

Terminated

2017-01-05

Reason

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

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 LMGRA@Leica-Microsystems.com 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: Combination.Products@LeicaBiosystems.com 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

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.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

NJT

Firm FEI

3000210133

Firm city

Buffalo Grove

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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