Device recall
Z-2298-2020: HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic…
FDA device recall · Class II · Hardy Diagnostics
Key facts
| Recall number (Z-number) | Z-2298-2020 |
|---|---|
| Recall event | 85412 |
| 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 for susceptibility… |
| Product code | JSO |
| Recalling firm | Hardy Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2021 |
| 510(k) numbers | K102922 |
| FEI number | 2022807 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database