Recall Z-1671-2016— Ab Sciex
Class II · Terminated
Class II FDA medical device recall by Ab Sciex, initiated 2016-03-25, terminated 2016-05-23. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Under certain conditions, mass spectrometers may report incorrect quantitative results..
- Recalling firm
- Ab Sciex
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-25
- Terminated
- 2016-05-23
- Firm location
- Framingham, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.