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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 NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only, by trained, qualified laboratory personnel.
Recall Number Z-0686-2013
Classification Class II
Code Info Lot Numbers: 617341, 619236
Product Distributed Qty 180 kits (20 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.