Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HardyCHROM MRSA Recalled by Hardy Diagnostics Due to False Positive results due to the MSSA (methicillin-susceptible)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hardy Diagnostics directly.
Affected Products
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
Quantity: 3,580 ea (358 kits, pack of 10 in each)
Why Was This Recalled?
False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.
Where Was This Sold?
This product was distributed to 12 states: AZ, CA, IA, KS, MO, MT, OR, TX, UT, WA, WI, WY
About Hardy Diagnostics
Hardy Diagnostics has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report