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

Recall Z-3121-2017 — Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Glypican-3 protein in formalin-fixed, paraffin-embedded tissue stained in

U.S. FDA — Device Enforcement · United States · 2017-07-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3121-2017
Date of alert: 2017-07-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Leica Biosystems Richmond Inc.
Product category: device
Product type: Devices

Reported risk: A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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