PerkinElmer 226 Sample Collection Device Recalled for Labeling Mismatch
PerkinElmer is recalling 226 Sample Collection Devices because the serial numbers on the pack labels did not match the devices inside.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation and labeling mismatch, fitting the 'Low' severity criteria for documentation issues.
Plain-English summary
PerkinElmer Health Sciences, Inc. is recalling 164,952 PerkinElmer 226 Sample Collection Devices. The recall involves Lot Number 40020001, with serial numbers ranging from 06879601 to 06879700. The devices were distributed in the state of Ohio.
The recall was initiated because the serial numbers printed on the pack labels did not match the serial number range of the devices contained within the pack. This is a documentation and labeling discrepancy.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices. No illnesses or injuries are reported in the source text.
The recalled product
- Product
- PerkinElmer 226 Sample Collection Device
- Manufacturer
- PerkinElmer Health Sciences, Inc.
- Hazard
- Affected units
- 164,952
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 (2)
- UDI: (01)50812589020011(17)200831(10)40020001
- Serial Numbers: 06879601-06879700
Distribution
Distributed in 1 state:
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