FDA-Device2013-10-30Class II
Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Perkin Elmer Health Sciences, Inc.
Hazard
Some devices may be contaminated on the back side of the device with glue in the blood application area.
Sold states
US distribution in OH
Affected count
65,984 devices
Manufactured in
17 P & N Drive, N/A, Greenville, SC, United States
Products
Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0030-2014Don't want to check this manually?
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