Z-2264-2020 Class III Terminated
FDA device recall Z-2264-2020 was initiated by PerkinElmer Health Sciences, Inc. on December 19, 2017 and is designated Class III. 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. The recall status is terminated (terminated March 26, 2021). Affected quantity: 164,952 devices.
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2020
- Initiation Date
- December 19, 2017
- Termination Date
- March 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 164,952 devices
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.
Distribution Pattern
US distribution in the state of Ohio
Code Information
UDI: (01)50812589020011(17)200831(10)40020001; Serial Numbers: 06879601-06879700