Home / Recalls / Medical Devices
Primus Corporation recalls Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
Recalled November 11, 2020 · FDA recall Z-0321-2021 · Primus
Hazard
The product did not receive pre-market approval or clearance. · FDA Class II
Units
97 devices (USA only)
Sold at
US - Arizona, California, District of Columbia, Florida, Georgia, Illinois, Louisiana, Massachusetts, Michigan, Missouri, Nebraska, New Jersey, Nevada, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin OUS - Bahrain, Iran, Malaysia, Saudi Arabia, Taiwan, Turkey, UAE, UK, Vietnam
Description
The product did not receive pre-market approval or clearance.
Product
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
Manufacturer(s)
Primus Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →