Devices

Device Recall Genetic Screening Processor (GSP

Model / Serial
Serial Numbers: 20210239 20210243 20210244 20210245 20210246 20210247 20210248 20210249 20210250 20210251 20210252 20210253 20210254 20210255 20210256 20210257 20210258 20210259 20210260 20210261 20210262 20210263 20210264 20210265
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
MA, SC, TX, AL OUS: China, Mexico, Peru, Morocco, Italy, Finland, Ecuador, Brazil
Product Description
Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 || Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
Manufacturer
PerkinElmer Life and Analytical Sciences, Wallac, OY
1 Event
- Recall of Device Recall Genetic Screening Processor (GSP

Manufacturer

PerkinElmer Life and Analytical Sciences, Wallac, OY

Manufacturer Address
PerkinElmer Life and Analytical Sciences, Wallac, OY, Mustionkatu 6, P.O. Box 10, Turku Finland
Manufacturer Parent Company (2017)
Perkin Elmer Inc.
Source
USFDA

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