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

AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031231 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing t — recall Z-2529-2016

U.S. FDA — Device Enforcement · United States · 2016-06-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2529-2016
Date of alert: 2016-06-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ab Sciex
Product category: device
Product type: Devices

Reported risk: MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.

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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