Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
This recall has been terminated (originally issued January 27, 2017).
- Recall Initiated
- January 5, 2017
- Posted
- January 27, 2017
- Terminated
- August 24, 2017
- Recall Number
- Z-1107-2017
- Quantity
- 24 instruments and 3 spare disk remover modules
- Firm Location
- Turku Finland
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
MA, SC, TX, AL OUS: China, Mexico, Peru, Morocco, Italy, Finland, Ecuador, Brazil
Lot / Code Info
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
Root Cause
Component change control
Action Taken
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.