HardyCHROM MRSA — Class II medical device recall Z-2298-2020

Terminated recall by Hardy Diagnostics, reported 2020-06-17, distributed in AZ, CA, GU, IA, KS, MO, MT, OR…. False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) bre

Recall number	`Z-2298-2020`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Hardy Diagnostics, Santa Maria, CA, United States
Recall initiated	2019-11-14
Classified	2020-06-08
Reported by FDA	2020-06-17
Terminated	2021-04-28
Distributed	AZ, CA, GU, IA, KS, MO, MT, OR, PR, TX, UT, VI, WA, WI, WY
Countries outside the US	KE
Pathogens	staphylococcus
UPC / GTIN / UDI-DI	`00816576020140`, `08165760201400`
Lot numbers	`447694`
Model numbers	`447694`, `G307`

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2298-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.