Z-0030-2014 Class II Terminated
FDA device recall Z-0030-2014 was initiated by Perkin Elmer Health Sciences, Inc. on September 5, 2013 and is designated Class II. Reason for recall: Some devices may be contaminated on the back side of the device with glue in the blood application area. The recall status is terminated (terminated July 17, 2014). Affected quantity: 65,984 devices.
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2013
- Initiation Date
- September 5, 2013
- Termination Date
- July 17, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65,984 devices
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.
Distribution Pattern
US distribution in OH
Code Information
Job number: 313119, Item Lot number: Ohio HEA 2518, Serial numbers: 06132903 - 06198900.