FDA recall Z-2264-2020

PerkinElmer Health Sciences, Inc. · Class III · device

Product

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

US distribution in the state of Ohio

Key facts

Status
Terminated
Initiation date
2017-12-19
Report date
2020-06-10
Termination date
2021-03-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Greenville, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2264-2020