FDA (Devices) recall action 76165
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
PerkinElmer is recalling 24 Genetic Screening Processor instruments because defective ball bushing axles may corrode in humid conditions, risking contamination of sample wells.
PerkinElmer is recalling Spare Disk Remover Modules because defective axles may corrode in humid conditions, potentially contaminating test plates.