Devices

Device Recall Perkin Elmer NEONATAL TOTAL GALACTOSE KIT

Model / Serial
Lot Numbers: 618201, 619200, 618263
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution.
Product Description
NEONATAL TOTAL GALACTOSE KIT || Product Numbers: 3029-0010, 3029-001B. || This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia.
Manufacturer
Perkinelmer
1 Event
- Recall of Device Recall Perkin Elmer NEONATAL TOTAL GALACTOSE 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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