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FDAJanuary 26, 2018device

QUANTA-Lyser 240 EIA, Part #GS0241. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mountin...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.

What to do

FDA enforcement status: Terminated

Brands named

inova diagnosticsinova

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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