PerkinElmer Genetic Screening Processor Recalled for Corroding Axles
PerkinElmer is recalling 24 Genetic Screening Processor instruments because defective ball bushing axles may corrode in humid conditions, risking contamination of sample wells.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential contamination of sample wells due to corrosion, which poses a risk of harm to the integrity of in vitro diagnostic results, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
PerkinElmer Life and Analytical Sciences, Wallac, OY is recalling 24 Genetic Screening Processor (GSP) instruments and 3 spare disk remover modules. The recall is due to defective ball bushing axles that may corrode when exposed to humid conditions. The instruments are intended for the in vitro quantitative and qualitative determination of analytes in body fluids.
The firm identified that deterioration of the axle material can result in corrosion deposits. These corrosion particles may contaminate the wells of the sample plates, or the corrosion may cause movement issues leading to spillage and further contamination. The affected units were distributed in Massachusetts, South Carolina, Texas, and Alabama, as well as in China, Mexico, Peru, Morocco, Italy, Finland, Ecuador, and Brazil.
The recall covers specific serial numbers ranging from 20210239 to 20210265. Users of these instruments should contact PerkinElmer for instructions on how to address the defect and prevent potential sample contamination.
The recalled product
- Product
- Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
- Hazard
Distribution
Part of a larger recall action
This product is one of 2 recalled by PerkinElmer Life and Analytical Sciences, Wallac, OY under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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