Medical device recalls Moderate risk

Ab Sciex recalls AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass…

Recall date
March 25, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1671-2016
FDA classification
Class II
Brand / firm
Ab Sciex
Sold / distributed
Distributed to the state of NC.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.

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