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

AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive b — recall Z-0619-2014

U.S. FDA — Device Enforcement · United States · 2013-12-11 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0619-2014
Date of alert: 2013-12-11
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: AdvanDx, Inc.
Product category: device
Product type: Devices

Reported risk: Kits incompatible with certain fluorescence microscope light sources

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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