Rappel de Device Recall Genetic Screening Processor (GSP

Recall

76165

Class 2

Z-1107-2017

2017-01-05

2017-01-27

Terminated

United States

2017-08-24

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152425

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 recall was initiated on January 5, 2017 via email sent through the PerkinElmer Technical Support group located in Akron Ohio. Actions to be taken by user: 1. As instructed in the analyte specific kit inserts, the use of Kit Controls is required to assure the day-to-day validity of results. Patient results should only be reported if control results for the assay meet the laboratorys established criteria for acceptability. 2. If a movement error occurs customers will be directed to contact their local PerkinElmer field service representative. The movement error may indicate deterioration of the axle and therefore the use of the instrument should be avoided until field service personnel have inspected the status of the ball bushing axles or replaced affected ball bushing axles. Actions to be taken by the PerkinElmer: As a corrective action, PerkinElmer will replace the affected ball bushing axles in all the GSP instruments identified in this FSCA/Recall. The replacement may take place either as part of the initial installation activity before the instrument is used, scheduled periodic maintenance, or during a dedicated service visit. This field correction is considered as mandatory by the manufacturer. Customers will be contacted by PerkinElmer to arrange the field service visit.