# FDA recall Z-2051-2020

> **Cardinal Health Inc.** · Class II · device recall initiated 2020-04-20.

## 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

- **Recall number:** Z-2051-2020
- **Recalling firm:** Cardinal Health Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2051-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2051-2020. Source: US FDA. Licensed CC0.

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