Kansas City, MO, United States
Primus Corporation recalls
1 recall recorded since 2018, most recently on 9 October 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 9 October 2020
- Terminated
- 4 November 2021
- Reason
- The product did not receive pre-market approval or clearance.
- Distribution
- 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,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0321-2021
- Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.