Reported Feb 8, 2017 · Terminated
Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative and qualitative determination of…
PerkinElmer Life and Analytical Sciences, Wallac, OY
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PerkinElmer Life and Analytical Sciences, Wallac, OY · Mustionkatu 6 · Turku, N/A · N/A
Is this the product you have?
- Spare Disk Remover Module
- Product Number61001820 Intended for in vitro quantitative and qualitative determination of analytes in body fluids
- Lot codes and dates
- N/A
- Amount recalled
- 24 instruments and 3 spare disk remover modules
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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