# FDA recall Z-0321-2021

> **Primus Corporation** · Class II · device recall initiated 2020-10-09.

## Product

Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation

## Reason for recall

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, Vietnam

## Key facts

- **Recall number:** Z-0321-2021
- **Recalling firm:** Primus Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-09
- **Report date:** 2020-11-11
- **Termination date:** 2021-11-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Kansas City, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0321-2021

## Citation

> AI Analytics. FDA recall Z-0321-2021. Retrieved 2026-09-22 from https://api.ai-analytics.org/recall/Z-0321-2021. Source: US FDA. Licensed CC0.

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