Lower riskMedical device recall · FDA · Published November 14, 2019
HardyCHROM MRSA G307: False Positive Risk from MSSA Breakthrough
Hardy Diagnostics recalls HardyCHROM MRSA G307 lot 447694 due to false positive results from MSSA breakthrough. This medium may misidentify MRSA in nasal tests.
False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.
Take action
Contact the company
📍Recalling firmHardy Diagnostics1430 W McCoy Ln · Santa Maria, CA 93455-1005
“HardyCHROM MRSA G307: False Positive Risk from MSSA Breakthrough.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66525-hardychrom-mrsa-g307-false-positive-risk-from-mssa-breakthrough. Based on FDA recall #Z-2298-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2298-2020%22&limit=1).
Hardy Diagnostics voluntarily recalled HardyCHROM MRSA,REF; G307, LOT: 447694 due to false positive results, according to the FDA on Nov. 14, 2019.
How to tell if you have it
HardyCHROM MRSA,REF; G307, LOT: 447694
UPC 08165760201400
The hazard
The recall addresses false positive results caused by the breakthrough of methicillin-susceptible Staphylococcus aureus (ATCC 29213) when it should have been inhibited.
Context
GovInfoNow's records show Hardy Diagnostics has 6 other recalls on record since Oct. 6, 2020. Other recent recalls of similar products include the Diagnostica Stago Asserachrom HPIA Kit Recall (Dec. 15, 2025) and the Hologic Aptima HPV Assay Kit Recall (Feb. 18, 2026).
How to tell if you have this one
Check the lot number on the container, which should be 447694 for this recall. The product is labeled as HardyCHROM MRSA,REF; G307. It's a 10-plate sleeve used for nasal MRSA testing.
Brand
Hardy Diagnostics
Product
HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Look for the lot number 447694 on the container to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed in 12 states and Puerto Rico.
Listed by the agency
Not listed
FDA 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,” States read from FDA’s own wording; “not listed” means the notice does not name it.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2298-2020 (November 14, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2298-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.