Medical device recalls Moderate risk

Primus Corporation recalls Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation

Recall date
October 9, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0321-2021
FDA classification
Class II
Brand / firm
Primus Corporation
Sold / distributed
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, V…

Why it was recalled

The product did not receive pre-market approval or clearance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation

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