Medline Industries Inc recalls Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test ca…

Recall date

March 15, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1407-2021

FDA classification

Class II

Brand / firm

Medline Industries Inc

Sold / distributed

US Nationwide distribution in the state of Ohio.

Why it was recalled

Possible false negative or false positive results due to the product being 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

Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.