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

Recall Z-0808-2016 — Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use states that Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of t

U.S. FDA — Device Enforcement · United States · 2015-11-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0808-2016
Date of alert: 2015-11-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Leica Microsystems, Inc.
Product category: device
Product type: Devices

Reported risk: The Firm informed the importer/distributor, Leica Microsystems, a manufacturing error occurred during the filling of some containers of the Bond Polymer Refine Red Detection DS9390 kits, which may result in inadequate staining.

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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