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U.S. Department of Health and Human Services

Enforcement Report - Week of January 23, 2013

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Product Detail

Product Description NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.
Recall Number Z-0688-2013
Classification Class II
Code Info Lot Numbers: 618201, 619200, 618263
Product Distributed Qty 3029-0010 =1562 kits (10 plats/kit) and 3029-001B=13 kits (50plates/kit)
Reason For Recall Truncated V-Bottomed Microplate Wells used in assays contain defective wells.

Event Detail

Event Id 63771
Product Type Devices
Status Ongoing
Recalling Firm Perkinelmer
City Waltham
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-26
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Nationwide Distribution.