FDAFDA · Food and drugs·Recall number Z-0686-2013
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.
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: 617341, 619236
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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