Spare Disk Remover Module — Class II medical device recall Z-1108-2017
Terminated recall by PerkinElmer Life and Analytical Sciences, Wallac, OY, reported 2017-02-08, distributed in AL, MA, SC, TX. The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humi
| Recall number | Z-1108-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PerkinElmer Life and Analytical Sciences, Wallac, OY, Turku, N/A, Finland |
| Recall initiated | 2017-01-05 |
| Classified | 2017-01-27 |
| Reported by FDA | 2017-02-08 |
| Terminated | 2017-08-24 |
| Distributed | AL, MA, SC, TX |
| Countries outside the US | BR, CN, EC, FI, IT, MA, MX, PE |
Product
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.