FDA Device recall Z-2298-2020
HardyCHROM MRSA,REF
- FDA Device
- Class II
- terminated
- Published 2020-06-17
On 2020-06-17 the FDA classified a Class II recall of HardyCHROM MRSA,REF by Hardy Diagnostics, citing false Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2298-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-14 |
| Published | 2020-06-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Hardy Diagnostics |
| Distribution | AZ, CA, IA, KS, MO, MT, OR, PR, TX, UT, WA, WI, WY |
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 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
Reason
False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.
Identifiers
| code_info | Catalogue no.: G307, Lot number 447694 HDx, UDI # 00816576020140 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2298-2020%22
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