Recall Z-0030-2014— Perkin Elmer Health Sciences, Inc.
Class II · Terminated
Class II FDA medical device recall by Perkin Elmer Health Sciences, Inc., initiated 2013-09-05, terminated 2014-07-17. It names one FDA 510(k) clearance: K121864. 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.. Reason: Some devices may be contaminated on the back side of the device with glue in the blood application area..
- Recalling firm
- Perkin Elmer Health Sciences, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-05
- Terminated
- 2014-07-17
- Firm location
- Greenville, SC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Some devices may be contaminated on the back side of the device with glue in the blood application area.
Data sourced from openFDA. This site is unofficial and independent of the FDA.