# FDA recall Z-0919-2021

> **Hardy Diagnostics** · Class II · device recall initiated 2020-12-21.

## Product

Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml

## Reason for recall

Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.

## Distribution

U.S.: CA, UT, MI, Puerto Rico, IN, CT, AZ, GA, MA, TN, WA    O.U.S. None

## Key facts

- **Recall number:** Z-0919-2021
- **Recalling firm:** Hardy Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-21
- **Report date:** 2021-02-03
- **Termination date:** 2022-09-28

- **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-0919-2021

## Citation

> AI Analytics. FDA recall Z-0919-2021. Retrieved 2026-09-09 from https://api.ai-analytics.org/recall/Z-0919-2021. Source: US FDA. Licensed CC0.

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