PerkinElmer Spare Disk Remover Module Recall Due to Corrosion Risk
PerkinElmer is recalling Spare Disk Remover Modules because defective axles may corrode in humid conditions, potentially contaminating test plates.
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 test plates due to corrosion, which is a risk-of-harm scenario where injury or illness has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
PerkinElmer Life and Analytical Sciences, Wallac, OY is recalling 24 instruments and 3 spare disk remover modules (Product Number: 61001820). These modules are intended for the in vitro quantitative and qualitative determination of analytes in body fluids.
The firm identified that the ball bushing axles in the GSP instrument are defective. When exposed to humid conditions, the axle material is at risk of corroding. This deterioration can result in corrosion particles contaminating the wells of test plates or causing movement issues that lead 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. Users should stop using the affected modules and contact PerkinElmer for instructions on remediation.
The recalled product
- Product
- Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative and qualitative determination of analytes in body fluids.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- N/A
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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