Recall Z-1108-2017 ยท KHO Fluorometer, For Clinical Use
PerkinElmer Life and Analytical Sciences, Wallac, OY
Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
| Date | Jan 27, 2017 (initiated Jan 5, 2017) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component change control |
| Action | 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 o |
| Quantity | 24 instruments and 3 spare disk remover modules |
| Distribution | MA, SC, TX, AL OUS: China, Mexico, Peru, Morocco, Italy, Finland, Ecuador, Brazil |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.