Device product
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.
Z-0030-2014
Product summary
- Event
- Event 66310
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65,984 devices
- Official record key
device-enforcement:Z-0030-2014
Official wording
Reason: Some devices may be contaminated on the back side of the device with glue in the blood application area.
Code information: Job number: 313119, Item Lot number: Ohio HEA 2518, Serial numbers: 06132903 - 06198900.
Distribution pattern: US distribution in OH
Derived failure modes
-
Unknown
Some devices may be contaminated on the back side of the device with glue in the blood application area.