PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: September 17, 2014 Initiated: July 15, 2014 #Z-2609-2014

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

Details

Recalling Firm
Ab Sciex
Units Affected
6 units
Distribution
FL, NC, OK, PA, TX
Location
Framingham, MA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Ab Sciex. Units affected: 6 units.
Why was this product recalled?
Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis
Which agency issued this recall?
This recall was issued by the FDA Devices on September 17, 2014. Severity: Moderate. Recall number: Z-2609-2014.