Device product

PerkinElmer 226 Sample Collection Device

Z-2264-2020

December 19, 2017

Class III

Product summary

Firm: PerkinElmer Health Sciences, Inc.
Event: Event 85630
Status: Terminated
Classification: Class III
Quantity: 164,952 devices
Official record key: device-enforcement:Z-2264-2020

Official wording

Reason: PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.

Code information: UDI: (01)50812589020011(17)200831(10)40020001; Serial Numbers: 06879601-06879700

Distribution pattern: US distribution in the state of Ohio

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.