Hardy Diagnostics

FDA Regulatory Profile

Summary

Total Recalls
19
510(k) Clearances
108
Inspections
8
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2041-2025Class IIHardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, May 6, 2025
Z-1835-2021Class IIQuickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.April 16, 2021
Z-0919-2021Class IIBrain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-2December 21, 2020
Z-0655-2021Class IIViral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM TOctober 23, 2020
Z-0441-2021Class IIIStrep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499October 6, 2020
Z-2298-2020Class IIHardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualNovember 14, 2019
Z-2146-2016Class IIQuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, May 24, 2016
Z-1571-2016Class IIHardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemoMarch 21, 2016
Z-0470-2016Class IIFB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria brotNovember 18, 2015
Z-2463-2015Class IIHardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplaJuly 9, 2015
Z-2278-2015Class IIHardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes/boJune 26, 2015
Z-2277-2015Class IIHardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeJune 26, 2015
Z-2276-2015Class IIHardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 platJune 26, 2015
Z-2279-2015Class IIHardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5mJune 26, 2015
Z-2273-2015Class IIHardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packagedJune 26, 2015
Z-2275-2015Class IIHardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeJune 26, 2015
Z-2274-2015Class IIHardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box June 26, 2015
Z-2192-2015Class IIHardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100June 24, 2015
Z-1444-2015Class IIHardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327March 4, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K253105HardyDisk AST Cefiderocol 30µg (FDC30)November 20, 2025
K250956HardyDisk AST Gepotidacin 10µg (GEP10)June 26, 2025
K250454HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)May 15, 2025
K233534Viral Transport MediumAugust 2, 2024
K241060HardyDisk AST Cefiderocol 30µg (FDC30)July 18, 2024
K231568HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)July 6, 2023
K230827HardyDisk AST Rezafungin 5µg (RZF5)June 1, 2023
K193504HardyDisk AST Cefiderocol 30ug (FDC30)January 23, 2020
K192326HardyDisk AST Lefamulin 20µg (LMU20)September 19, 2019
K191931HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)July 31, 2019
K190553HardyCHROM CREApril 29, 2019
K183298HardyDisk AST Omadacycline 30µg (OMC30)January 18, 2019
K182357HardyDisk AST Eravacycline 20µg (ERV20)September 26, 2018
K181700HardyDisk AST Plazomicin 30ug (PLZ30)July 10, 2018
K173903Granada MediumMarch 22, 2018
K172621HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)October 3, 2017
K171975HardyDisk AST Delafloxacin 5 µg (DLX5)August 1, 2017
K170586Strep B Carrot Broth One-StepMay 22, 2017
K170481Strep B Carrot Broth KitMay 16, 2017
K170127HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40March 14, 2017