HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the q...
FDA Device Recall #Z-2298-2020 — Class II — November 14, 2019
Recall Summary
| Recall Number | Z-2298-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 14, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Hardy Diagnostics |
| Location | Santa Maria, CA |
| Product Type | Devices |
| Quantity | 3,580 ea (358 kits, pack of 10 in each) |
Product Description
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 for Recall
False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.
Distribution Pattern
U.S. Distribution in the states of WI, CA, WA, IA, MT, UT, AZ, WY, KS, MO, OR, TX, VI, including PR and Guam. OUS: British Virgin Islands, Kenya,
Lot / Code Information
Catalogue no.: G307, Lot number 447694 HDx, UDI # 00816576020140
Other Recalls from Hardy Diagnostics
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2041-2025 | Class II | HardyCHROM CRE, selective and differential cult... | May 6, 2025 |
| Z-1835-2021 | Class II | Quickslide GramPro 1 Automated Gram Stanier is ... | Apr 16, 2021 |
| Z-0919-2021 | Class II | Brain Heart Infusion Agar with 6 ug/ml Vancomyc... | Dec 21, 2020 |
| Z-0655-2021 | Class II | Viral Transport Medium, 3ml, Ref: R99, Containe... | Oct 23, 2020 |
| Z-0441-2021 | Class III | Strep B Carrot Broth One-Step, Ref. Z40, UDI: ... | Oct 6, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.