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Recall Observatory FDA recall evidence

Device product

PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.

Z-2756-2017

May 31, 2017

Class III

Product summary

Firm
PerkinElmer Health Sciences, Inc.
Event
Event 77668
Status
Terminated
Classification
Class III
Quantity
99,968 units
Official record key
device-enforcement:Z-2756-2017

Official wording

Reason: PerkinElmer 226 Sample Collection Devices Lot Number 317114 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: lot numbers 317113 and 317114

Distribution pattern: US Distribution to the state of : AL

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.