Z-1108-2017 Class II Terminated
FDA device recall Z-1108-2017 was initiated by PerkinElmer Life and Analytical Sciences, Wallac, OY on January 5, 2017 and is designated Class II. 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 ax… The recall status is terminated (terminated August 24, 2017). Affected quantity: 24 instruments and 3 spare disk remover modules.
Recall Details
- Product Type
- Devices
- Report Date
- February 8, 2017
- Initiation Date
- January 5, 2017
- Termination Date
- August 24, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 instruments and 3 spare disk remover modules
Product Description
Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
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 Pattern
MA, SC, TX, AL OUS: China, Mexico, Peru, Morocco, Italy, Finland, Ecuador, Brazil
Code Information
N/A