PerkinElmer 226 Sample Collection Device Recalled for Labeling Mismatch
PerkinElmer is recalling 226 Sample Collection Devices because pack label serial numbers 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 indicates the product is not likely to cause adverse health consequences. The issue is a documentation and labeling mismatch rather than a functional defect or contamination.
Plain-English summary
PerkinElmer Health Sciences, Inc. is recalling 99,968 units of the PerkinElmer 226 Sample Collection Device. This device is used to collect and transport whole blood specimen spots to a laboratory for Newborn Screening.
The recall was initiated because Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack. The affected units were distributed to the state of Alabama.
Consumers should stop using the affected devices and contact PerkinElmer Health Sciences, Inc. for instructions on how to return or dispose of the product.
The recalled product
- Product
- PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
- Manufacturer
- PerkinElmer Health Sciences, Inc.
- Hazard
- Affected units
- 99,968
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)
- lot numbers 317113 and 317114
Distribution
Distributed in 1 state:
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