Inova Diagnostics Incorporated recalls QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated, high-throughput, bench top system designed for…

Recall date

January 26, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1221-2018

FDA classification

Class II

Brand / firm

Inova Diagnostics Incorporated

Sold / distributed

There was no U.S. distribution. Distribution was made to Panama and United Kingdom.

Why it was recalled

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

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

What was recalled

QUANTA-Lyser 240 IFA, Part #GS0242. 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 mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.