FDANovember 14, 2019device
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 susceptibilit...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.
What to do
FDA enforcement status: Terminated
Brands named
hardy diagnosticshardy
UPCs
0081657602014008165760201400
Recall history
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