Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0521-2013 — 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-TdT-339; packaged in 7

U.S. FDA — Device Enforcement · United States · 2012-11-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0521-2013
Date of alert: 2012-11-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Leica Microsystems, Inc.
Product category: device
Product type: Devices

Reported risk: RTU-TdT-339 is not stable up to the expiry date on the product labeling, affecting the staining intensity.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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