# FDA recall Z-2298-2020

> **Hardy Diagnostics** · Class II · device recall initiated 2019-11-14.

## Product

HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA). Not intended to diagnose infection of guide therapy. Further testing required for susceptibility or typing.     Container Type: 15 x 100mm monoplate  Packaged: 10 plates/sleeve  STORAGE: 2-8 degree C on receipt, LIGHT SENSITIVE     IVD UDI: (01)08165760201400 (10)447694 (17)191206

## Reason for recall

False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.

## Distribution

U.S. Distribution in the states of WI, CA, WA, IA, MT, UT, AZ, WY, KS, MO, OR, TX, VI, including PR and Guam.    OUS: British Virgin Islands, Kenya,

## Key facts

- **Recall number:** Z-2298-2020
- **Recalling firm:** Hardy Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-14
- **Report date:** 2020-06-17
- **Termination date:** 2021-04-28

- **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-2298-2020

## Citation

> AI Analytics. FDA recall Z-2298-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2298-2020. Source: US FDA. Licensed CC0.

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