FDA recall Z-1222-2018

Inova Diagnostics Incorporated · Class II · device

Product

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 mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-01-26
Report date
2018-04-04
Termination date
2018-05-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1222-2018