Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0823-2016·Announced 2016-03-02

Leica Bond Polymer Refine Detection System Recalled for Inadequate Staining

Leica Microsystems is recalling the Bond Polymer Refine Detection System because it may not provide adequate staining when used with specific protocols.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a performance issue (inadequate staining) without reporting any patient injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary recalls where harm has not been reported.

Plain-English summary

Leica Microsystems, Inc. is recalling the Bond Polymer Refine Detection System and Novolink Polymer Detection System. The recall involves 1,700 units of the Bond Ready-to-Use Primary Antibody PAX-5 (1EW) and specific lots of the Bond Polymer Refine Detection Kit.

The recall was initiated because the detection systems may not provide adequate staining when using a detection protocol where the Peroxide Block or Peroxidase Block component is applied after the primary marker incubation, as specified in the Instructions for Use. This issue affects the qualitative identification of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining.

The affected products were distributed to consignees in numerous US states and territories, as well as to foreign consignees in over 30 countries. Users of these products should stop using the affected kits and contact Leica Microsystems for further instructions.

The recalled product

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.
Manufacturer: Leica Microsystems, Inc.
Category: Medical Device — In Vitro Diagnostic Reagent
Hazard: inadequate-staining
performance-issue
Affected units: 1,700

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

42388
42474
42486
42499
42555
42570
42579
42627
42645
42683
42780
42802
42823
42852
43050.

Distribution

Distributed in 37 states:

Same manufacturer · Leica Microsystems, Inc.

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