Strep B Carrot Broth One-Step recalled over temperature-control failures

Recall date

April 20, 2020

Source

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

Official notice title

Cardinal Health Inc. recalls Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptoc…

Recall number

Z-2051-2020

FDA classification

Class II

Brand / firm

Cardinal Health Inc.

Sold / distributed

US Nationwide distribution NC, KS, and AL.

Why it was recalled

Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.

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

What was recalled

Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment prior to vaginal delivery in order to prevent infection of the neonate.