PlainRecalls
FDA Devices Moderate Class II Terminated

AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass spectrometers for in vitro diagnostic use only.

Reported: May 25, 2016 Initiated: March 25, 2016 #Z-1671-2016

Product Description

AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass spectrometers for in vitro diagnostic use only.

Reason for Recall

Under certain conditions, mass spectrometers may report incorrect quantitative results.

Details

Recalling Firm
Ab Sciex
Units Affected
2 units
Distribution
Distributed to the state of NC.
Location
Framingham, MA

Frequently Asked Questions

What product was recalled?
AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass spectrometers for in vitro diagnostic use only.. Recalled by Ab Sciex. Units affected: 2 units.
Why was this product recalled?
Under certain conditions, mass spectrometers may report incorrect quantitative results.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 25, 2016. Severity: Moderate. Recall number: Z-1671-2016.