Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
Reported: November 11, 2020 Initiated: October 9, 2020 #Z-0321-2021
Product Description
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
Reason for Recall
The product did not receive pre-market approval or clearance.
Details
- Recalling Firm
- Primus Corporation
- Units Affected
- 97 devices (USA only)
- 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, Vietnam
- Location
- Kansas City, MO
Frequently Asked Questions
What product was recalled? ▼
Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation. Recalled by Primus Corporation. Units affected: 97 devices (USA only).
Why was this product recalled? ▼
The product did not receive pre-market approval or clearance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 11, 2020. Severity: Moderate. Recall number: Z-0321-2021.
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