FDAFDA · Food and drugs·Recall number Z-0687-2013
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.
Published January 23, 2013 · Recall initiated: November 26, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Perkinelmer
- Distributor
- Nationwide Distribution.
- Lot
- Lot Numbers: 617253 , 617346, 618494 , 618653, 618764 , 619453
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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