Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0521-2013·Announced 2012-12-19

Leica TdT Staining Reagent Recalled for Stability Issues

Leica Microsystems is recalling 322 vials of Novocastra TdT Staining Reagent because the product is not stable up to its expiry date, affecting staining intensity.

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 hazard is limited to reduced staining intensity (a performance issue) rather than a direct physical injury or high-risk pathogen, fitting the 'Moderate' criteria for low-risk contamination or performance defects.

Plain-English summary

Leica Microsystems, Inc. is recalling 322 vials of Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent (Catalog No. RTU-TdT-339). The recall involves specific lot numbers 6001845 (expiry 2012-11) and 6009645 (expiry 2014-04), as well as expired lots 804804, 804805, 804806, 804809, 804810, and 804812.

The recall was initiated because the product is not stable up to the expiry date on the product labeling, which affects the staining intensity. This is an in vitro diagnostic reagent used for the qualitative identification of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections by light microscopy.

The affected products were distributed worldwide, including in the United States (Arkansas, California, Florida, Illinois, Maryland, Michigan, Minnesota, Missouri, North Carolina, Oregon, Rhode Island, Tennessee, Texas, and Wisconsin) and Canada. Users should stop using the affected lots and contact the manufacturer for further instructions.

The recalled product

Product: Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections; Catalog No.…
Manufacturer: Leica Microsystems, Inc.
Category: Medical Device — In Vitro Diagnostic Reagent
Hazard: stability-defect
performance-issue
Affected units: 322

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 (9)

Catalog No. RTU-TdT-339
lot numbers 6001845
expiry 2012-11 and 6009645
expiry 2014-04 The recall also included the folowing expired lots: 804804
804805
804806
804809
804810
804812

Distribution

Distributed in 14 states:

Same manufacturer · Leica Microsystems, Inc.

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