FDA recall Z-0321-2021

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

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

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