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

Recall Z-1652-2022 — FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010

U.S. FDA — Device Enforcement · United States · 2022-07-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1652-2022
Date of alert
2022-07-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Qiagen Sciences LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
169047135
Reported risk: Increased occurrence rate of false positive results, lead to a false positive sample result that could subsequently be incorrectly reported from the laboratory. A false positive result could lead to the risk of the patient being exposed to an inappropriate or suboptimal anti-cancer treatment and/or unnecessarily experiencing side effects
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.

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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.