FDA Device recall Z-1108-2017
Spare Disk Remover Module
- FDA Device
- Class II
- terminated
- Published 2017-02-08
On 2017-02-08 the FDA classified a Class II recall of Spare Disk Remover Module by Perkinelmer Life And Analytical Sciences Wallac Oy, citing 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. De….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1108-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-05 |
| Published | 2017-02-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Perkinelmer Life And Analytical Sciences Wallac Oy |
| Distribution | AL, MA, SC, TX |
Product
Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
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.
Identifiers
| code_info | N/A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1108-2017%22
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