FDA recall Z-1249-2021

Product

RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks to verify correct system measurement.

Reason for recall

Product was compromised during shipment.

Distribution

US Nationwide distribution in the states of KY, PA, OH.

Key facts

Status

Terminated

Initiation date

2021-01-25

Report date

2021-03-24

Termination date

2023-01-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1249-2021