PerkinElmer 226 Sample Collection Device
FDA Recall #Z-2264-2020 — Class III — December 19, 2017
Product Description
PerkinElmer 226 Sample Collection Device
Reason for Recall
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.
Recalling Firm
PerkinElmer Health Sciences, Inc. — Greenville, SC
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
164,952 devices
Distribution
US distribution in the state of Ohio
Code Information
UDI: (01)50812589020011(17)200831(10)40020001; Serial Numbers: 06879601-06879700
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated