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

Recall Z-2113-2014 — InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.

U.S. FDA — Device Enforcement · United States · 2014-07-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2113-2014
Date of alert
2014-07-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Biogenex Laboratories, Inc.
Product category
device
Product type
Devices
Reported risk: Product was distributed without 510(k) approval.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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