Company: Ab Sciex
Date of Enforcement Report: 9/17/2014
Class lI:
PRODUCT
AB SCIEX API 3200MD” LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens Part Number 5024543. Recall Number Z-2609-2014
REASON
Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis
RECALLING FIRM/MANUFACTURER
Ab Sciex, Framingham, MA on 7/15/2014 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
6 Units
DISTRIBUTION
FL, NC, OK, PA, TX
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