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.
What this means for you
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.
- 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
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