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PerkinElmer Life and Analytical Sciences, Wallac, OY recalls Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitat
Recalled February 8, 2017 · FDA recall Z-1107-2017 · PerkinElmer Life and Analytical Sciences, Wallac, OY
Hazard
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. · FDA Class II
Units
24 instruments and 3 spare disk remover modules
Sold at
MA, SC, TX, AL OUS: China, Mexico, Peru, Morocco, Italy, Finland, Ecuador, Brazil
Description
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.
Product
Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
Manufacturer(s)
PerkinElmer Life and Analytical Sciences, Wallac, OY
Made in
Finland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →