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U.S. Department of Health and Human Services

Enforcement Report - Week of October 30, 2013

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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
Distribution Pattern US distribution in OH

Product Detail

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