FDA-Device2018-04-04Class II
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.
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.
Sold states
There was no U.S. distribution. Distribution was made to Panama and United Kingdom.
Affected count
1 instrument
Manufactured in
9900 Old Grove Rd, San Diego, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1222-2018Don't want to check this manually?
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