Device product
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.
Z-0687-2013
Product summary
- Firm
- Perkinelmer
- Event
- Event 63771
- Status
- Terminated
- Classification
- Class II
- Quantity
- 819 kits (10 plates/kit)
- Official record key
device-enforcement:Z-0687-2013
Official wording
Reason: Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
Code information: Lot Numbers: 617253 , 617346, 618494 , 618653, 618764 , 619453
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.