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

Recalled April 4, 2018 · FDA recall Z-1221-2018 · Inova Diagnostics Incorporated

Hazard

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

Units

1 instrument

Sold at

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

Description

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

Product

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.

Manufacturer(s)

Inova Diagnostics Incorporated

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →