System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Clinical Chemistry · 21 CFR 862.1055
Amino acids, free carnitines and acylcarnitines test system is intended for the measurement and evaluation of amino acid, free carnitine and acylcarnitine concentrations from newborn whole blood filter paper samples. The quantitative analysis of the amino acids, free carnitines and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that should aid in identifying elevated levels of these metabolites for screening newborns for one or more of several metabolic disorders.
Recent MDR events
3 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
3 recall events for this product code
- PerkinelmerTerminatedJan 16, 2013
NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U.
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Z-0687-2013 · View FDA record ↗ - Perkin Elmer Life And AnalyticalTerminatedJun 9, 2005
Perkin ELmer Life and Analytical Sciences -NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit
Pump failure may effect data integrity
Z-0879-05 · View FDA record ↗ - PerkinElmer Life and Analytical Sciences, Wallac, OYTerminatedUnknown
NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184
There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may result when handling leaking succinylacetone reagent vials.
Z-1692-2018 · View FDA record ↗
Registered firms
4 firms currently registered for this product code
510(k) clearances
5 clearances for this product code
- Perkinelmer, Inc.Feb 7, 2020
K193103 · NeoBase 2 Non-derivatized MSMS Kit
- Wallac Oy, Subsidiary of Perkinelmer, Inc.Sep 4, 2018
K173568 · NeoBase 2 Non-derivatized MSMS Kit
- Perkinelmer, Inc.Aug 23, 2010
K093916 · NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U
- Perkinelmer, Inc.Jul 9, 2009
K083130 · NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040
- Perkinelmer Life Sciences, Inc.Aug 24, 2004
DEN040002 · NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970