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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
E-Mail
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
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