Devices

Device Recall Perkin Elmer NEOBASE NONDERIVATIZED MSMS KIT

Model / Serial
Lot Numbers: 617253 , 617346, 618494 , 618653, 618764 , 619453
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution.
Product Description
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.
Manufacturer
Perkinelmer
1 Event
- Recall of Device Recall Perkin Elmer NEOBASE NONDERIVATIZED MSMS KIT

Manufacturer

Perkinelmer

Manufacturer Address
Perkinelmer, 940 Winter Street, Waltham MA 02451
Manufacturer Parent Company (2017)
Perkin Elmer Inc.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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