# FDA recall Z-0441-2021

> **Hardy Diagnostics** · Class III · device recall initiated 2020-10-06.

## Product

Strep B Carrot Broth One-Step, Ref. Z40,  UDI: 00819398026499

## Reason for recall

Streptococcus culture medium contains an incorrect expiration date. The culture medium  outer box labeling contains an expiration date of  2021-11-10 instead of the correct expiration date of 2020-11-10

## Distribution

US: VA, AR, WI, ID, NY, AL, CA, MT, TX, MN,  NH, WA, NC, NY, AZ, AK, MO, FL, MI, WY, ID, CO, AL, MT, WY, Puerto Rico, and Guam

## Key facts

- **Recall number:** Z-0441-2021
- **Recalling firm:** Hardy Diagnostics
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-06
- **Report date:** 2020-11-18
- **Termination date:** 2021-05-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Maria, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0441-2021

## Citation

> AI Analytics. FDA recall Z-0441-2021. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-0441-2021. Source: US FDA. Licensed CC0.

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