The Recall Desk
LowFDA (Devices)·Z-2264-2020·Announced 2020-06-10

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.

What this means for you

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
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: