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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