FDA-Device2017-08-02Class III

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.

PerkinElmer Health Sciences, Inc.
Hazard

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.

Sold states
US Distribution to the state of : AL
Affected count
99,968 units
Manufactured in
17 P & N Drive, N/A, Greenville, SC, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2756-2017

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