Cardinal Health Inc.: Medical Device Recall in 2020 - (Recall #: Z-2051-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 20, 2020

Date Posted: May 27, 2020

Recall Number: Z-2051-2020

Event ID: 85509

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.

Status: Terminated

Product Quantity: N/A

Code Information:

All lots

Distribution Pattern:

US Nationwide distribution NC, KS, and AL.

Voluntary or Mandated:

Voluntary: Firm initiated