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U.S. Department of Health and Human Services

Enforcement Report - Week of January 23, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot Numbers: 617341, 619236 Class II Truncated V-Bottomed Microplate Wells used in assays contain defective wells. 180 kits (20 plates/kit) Z-0686-2013
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. Lot Numbers: 617253 , 617346, 618494 , 618653, 618764 , 619453 Class II Truncated V-Bottomed Microplate Wells used in assays contain defective wells. 819 kits (10 plates/kit) Z-0687-2013
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. Lot Numbers: 618201, 619200, 618263 Class II Truncated V-Bottomed Microplate Wells used in assays contain defective wells. 3029-0010 =1562 kits (10 plats/kit) and 3029-001B=13 kits (50plates/kit) Z-0688-2013
DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010 Lot Numbers: 618609 Class II Truncated V-Bottomed Microplate Wells used in assays contain defective wells. 56 kits (100 plates/kit) Z-0689-2013
Microplate, truncated V-bottomed lots included in the above listed products Product Number: 1380 5465. DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body. Lot Numbers: 616792 , 617141 , 617980 , 618319, 618664, 618831, 619175 Class II Truncated V-Bottomed Microplate Wells used in assays contain defective wells. Z-0690-2013
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