HardyCHROM MRSA Recall for False Positive Results
Hardy Diagnostics is recalling HardyCHROM MRSA kits because they may produce false positive results for methicillin-susceptible Staphylococcus aureus.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves false positive results in a medical diagnostic test, which is a risk-of-harm product issue where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Hardy Diagnostics is recalling HardyCHROM MRSA,REF; G307, Lot 447694. This product is a selective and differential chromogenic medium used for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA). The recall involves 3,580 units, packaged as 358 kits containing 10 plates each.
The recall is being issued because the product may produce false positive results. Specifically, the methicillin-susceptible Staphylococcus aureus (MSSA) strain ATCC 29213 may not be inhibited as intended, leading to breakthrough growth and incorrect identification.
The affected product was distributed in the United States in the states of WI, CA, WA, IA, MT, UT, AZ, WY, KS, MO, OR, TX, VI, including PR and Guam. It was also distributed in the British Virgin Islands and Kenya. Users should stop using the product and contact Hardy Diagnostics for further instructions.
The recalled product
- 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
- Manufacturer
- Hardy Diagnostics
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalogue no.: G307
- Lot number 447694 HDx
- UDI # 00816576020140
Distribution
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