Medical device recalls Moderate risk

Medline Industries Inc recalls RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglo…

Recall date
January 25, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1249-2021
FDA classification
Class II
Brand / firm
Medline Industries Inc
Sold / distributed
US Nationwide distribution in the states of KY, PA, OH.

Why it was recalled

Product was compromised during shipment.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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