FDA recall Z-2051-2020

Cardinal Health Inc. · Class II · device

Product

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.

Reason for recall

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.

Distribution

US Nationwide distribution NC, KS, and AL.

Key facts

Status
Terminated
Initiation date
2020-04-20
Report date
2020-05-27
Termination date
2020-07-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2051-2020