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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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Product Detail

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.
Recall Number Z-0030-2014
Classification Class II
Code Info Job number: 313119, Item Lot number: Ohio HEA 2518, Serial numbers: 06132903 - 06198900.
Product Distributed Qty 65,984 devices
Reason For Recall Some devices may be contaminated on the back side of the device with glue in the blood application area.

Event Detail

Event Id 66310
Product Type Devices
Status Ongoing
Recalling Firm Perkin Elmer Health Sciences, Inc.
City Greenville
State SC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-05
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern US distribution in OH