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

Recall Z-1152-2014 — HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue Manual Read of Digital Slides The ScanScope¿¿ System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pat

U.S. FDA — Device Enforcement · United States · 2014-02-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1152-2014
Date of alert: 2014-02-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Leica Biosystems Imaging, Inc.
Product category: device
Product type: Devices

Reported risk: In an abundance of caution, Aperio (now known as Lecia Biosystems) is providing additional information to clarify that the use of Digital IHC Breast/ER/Dako Image Analysis, Digital IHC Breast/HER2 Digital Read, Digital IHC Breast/HER2/Dako Image Analysis, Digital IHC Breast/PR Digital Read and Digital IHC Breast/PR/Dako Image Analysis with the RUO products identified in that earlier notification i

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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