Hardy Diagnostics
FDA Regulatory Profile
Hardy Diagnostics appears in FDA public data with 19 recalls, 109 510(k) clearances, 8 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2041-2025, Class II) was initiated on May 6, 2025. Its most recent 510(k) clearance was granted on May 11, 2026.
Summary
- Total Recalls
- 19
- 510(k) Clearances
- 109
- Inspections
- 8
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2041-2025 | Class II | HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, | May 6, 2025 |
| Z-1835-2021 | Class II | Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer. | April 16, 2021 |
| Z-0919-2021 | Class II | Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-2 | December 21, 2020 |
| Z-0655-2021 | Class II | Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM T | October 23, 2020 |
| Z-0441-2021 | Class III | Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499 | October 6, 2020 |
| Z-2298-2020 | Class II | HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qual | November 14, 2019 |
| Z-2146-2016 | Class II | QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, | May 24, 2016 |
| Z-1571-2016 | Class II | Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemo | March 21, 2016 |
| Z-0470-2016 | Class II | FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria brot | November 18, 2015 |
| Z-2463-2015 | Class II | HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monopla | July 9, 2015 |
| Z-2278-2015 | Class II | Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes/bo | June 26, 2015 |
| Z-2274-2015 | Class II | Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box | June 26, 2015 |
| Z-2276-2015 | Class II | Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plat | June 26, 2015 |
| Z-2277-2015 | Class II | Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/slee | June 26, 2015 |
| Z-2273-2015 | Class II | Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packaged | June 26, 2015 |
| Z-2275-2015 | Class II | Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/slee | June 26, 2015 |
| Z-2279-2015 | Class II | Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5m | June 26, 2015 |
| Z-2192-2015 | Class II | HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100 | June 24, 2015 |
| Z-1444-2015 | Class II | Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 | March 4, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10) | May 11, 2026 |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) | November 20, 2025 |
| K250956 | HardyDisk AST Gepotidacin 10µg (GEP10) | June 26, 2025 |
| K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | May 15, 2025 |
| K233534 | Viral Transport Medium | August 2, 2024 |
| K241060 | HardyDisk AST Cefiderocol 30µg (FDC30) | July 18, 2024 |
| K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) | July 6, 2023 |
| K230827 | HardyDisk AST Rezafungin 5µg (RZF5) | June 1, 2023 |
| K193504 | HardyDisk AST Cefiderocol 30ug (FDC30) | January 23, 2020 |
| K192326 | HardyDisk AST Lefamulin 20µg (LMU20) | September 19, 2019 |
| K191931 | HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) | July 31, 2019 |
| K190553 | HardyCHROM CRE | April 29, 2019 |
| K183298 | HardyDisk AST Omadacycline 30µg (OMC30) | January 18, 2019 |
| K182357 | HardyDisk AST Eravacycline 20µg (ERV20) | September 26, 2018 |
| K181700 | HardyDisk AST Plazomicin 30ug (PLZ30) | July 10, 2018 |
| K173903 | Granada Medium | March 22, 2018 |
| K172621 | HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) | October 3, 2017 |
| K171975 | HardyDisk AST Delafloxacin 5 µg (DLX5) | August 1, 2017 |
| K170586 | Strep B Carrot Broth One-Step | May 22, 2017 |
| K170481 | Strep B Carrot Broth Kit | May 16, 2017 |