Reported Jun 17, 2020 · Terminated
HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct…
Hardy Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hardy Diagnostics · 1430 W McCoy Ln · Santa Maria, CA · 93455-1005
Is this the product you have?
- HardyCHROM MRSA,REF; G307
- LOT447694, 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 Type15
- x 100mm monoplate Packaged10
- plates/sleeve STORAGE2-8 degree C on receipt
- LIGHT SENSITIVE IVD UDI(01)08165760201400 (10)447694 (17)191206
- Lot codes and dates
Catalogue no.: G307Lot number 447694 HDxUDI # 00816576020140
- Amount recalled
- 3,580 ea (358 kits, pack of 10 in each)
Where it was sold
Why it was recalled
False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.
This product could cause temporary or reversible health problems — stop using it.
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