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.
Recall
- Recall Number
- Z-0030-2014
- Event Number
- 66310
- Firm
- Perkin Elmer Health Sciences, Inc.
- FEI Number
- 3007145015
- Product Code
- JKA
- Status
- Terminated
- Root Cause
- Material/Component Contamination
- Initiated
- September 5, 2013
- Posted
- October 18, 2013
- Terminated
- July 17, 2014
- Address
- 17 P & N Drive, Greenville, SC, 29611
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.
Some devices may be contaminated on the back side of the device with glue in the blood application area.
The firm, Perkin Elmer, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated September 5, 2013 via email to its consignees. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately notify all submitting facilities and personnel that have received the PerkinElmer 226 Sample Collection Device of the potential glue contamination and to distribute the enclosed record of actions form to all submitting facilities/personnel and encourage them to perform the inspection activities as listed in the letter; and complete and return the enclosed Recall Response Form return it to PerkinElmer Health Sciences via fax to: 864-299-8797 or email to: [email protected]. Please contact PerkinElmer Health Sciences Greenville facility Quality Manager for further information 864-299-8787 (ext 104).
US distribution in OH
65,984 devices