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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 NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes ) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
Recall Number Z-0687-2013
Classification Class II
Code Info Lot Numbers: 617253 , 617346, 618494 , 618653, 618764 , 619453
Product Distributed Qty 819 kits (10 plates/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.
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