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.
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 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. RTU-Td
- Manufacturer
- Leica Microsystems, Inc.
- 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
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