Recall Z-2609-2014— Ab Sciex
Class II · Terminated
Class II FDA medical device recall by Ab Sciex, initiated 2014-07-15, terminated 2014-10-01. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis.
- Recalling firm
- Ab Sciex
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-15
- Terminated
- 2014-10-01
- Firm location
- Framingham, MA, United States
Product description
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.
Reason for recall
Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis
Data sourced from openFDA. This site is unofficial and independent of the FDA.