PerkinElmer Life and Analytical Sciences, Wallac, OY recalls Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitativ…

Recall date

January 5, 2017

Source

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

Recall number

Z-1107-2017

FDA classification

Class II

Brand / firm

PerkinElmer Life and Analytical Sciences, Wallac, OY

Sold / distributed

MA, SC, TX, AL OUS: China, Mexico, Peru, Morocco, Italy, Finland, Ecuador, Brazil

Why it was recalled

The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corrosion on the defective axles. Ball bushing axles may corrode and corrosion particle may cause contamination in the wells or the corrosion will cause movement issues and possibly spillage and causing contamination of the plate wells.

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

What was recalled

Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.