Hardy Diagnostics
Medical device manufacturer in Santa Maria, CA.
110510(k) clearances
0PMA approvals
20recalls
Device types
- JTN Susceptibility Test Discs, Antimicrobial 84
- JTO Discs, Strips And Reagents, Microorganism… 10
- JSO Culture Media, Antimicrobial Susceptibility… 5
- JTY Culture Media, For Isolation Of Pathogenic… 3
- JSM Culture Media, Non-Propagating Transport 3
- PQZ Gbs Culture Media, Selective And Differential 3
- LKS Device, Parasite Concentration 1
- JXC Kit, Screening, Yeast 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K262113 | HardyDisk AST Tebipenem 10µg (TBP10)JTN · Traditional | 08/20/2026SE |
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10)JTN · Traditional | 05/11/2026SE |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30)JTN · Traditional | 11/20/2025SE |
| K250956 | HardyDisk AST Gepotidacin 10µg (GEP10)JTN · Traditional | 06/26/2025SE |
| K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)JTN · Traditional | 05/15/2025SE |
| K233534 | Viral Transport MediumJSM · Traditional | 08/02/2024SE |
| K241060 | HardyDisk AST Cefiderocol 30µg (FDC30)JTN · Traditional | 07/18/2024SE |
| K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)JTN · Traditional | 07/06/2023SE |
| K230827 | HardyDisk AST Rezafungin 5µg (RZF5)JTN · Traditional | 06/01/2023SE |
| K193504 | HardyDisk AST Cefiderocol 30ug (FDC30)JTN · Traditional | 01/23/2020SE |
| K192326 | HardyDisk AST Lefamulin 20µg (LMU20)JTN · Traditional | 09/19/2019SE |
| K191931 | HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)JTN · Traditional | 07/31/2019SE |
| K190553 | HardyCHROM CREJSO · Traditional | 04/29/2019SE |
| K183298 | HardyDisk AST Omadacycline 30µg (OMC30)JTN · Traditional | 01/18/2019SE |
| K182357 | HardyDisk AST Eravacycline 20µg (ERV20)JTN · Traditional | 09/26/2018SE |
| K181700 | HardyDisk AST Plazomicin 30ug (PLZ30)JTN · Traditional | 07/10/2018SE |
| K173903 | Granada MediumPQZ · Traditional | 03/22/2018SE |
| K172621 | HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)JTN · Traditional | 10/03/2017SE |
| K171975 | HardyDisk AST Delafloxacin 5 µg (DLX5)JTN · Traditional | 08/01/2017SE |
| K170586 | Strep B Carrot Broth One-StepPQZ · Traditional | 05/22/2017SE |
| K170481 | Strep B Carrot Broth KitPQZ · Traditional | 05/16/2017SE |
| K170127 | HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40JTN · Traditional | 03/14/2017SE |
| K160512 | HardyCHROM ESBLJSO · Traditional | 11/15/2016SE |
| K152846 | HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40JTN · Traditional | 11/24/2015SE |
| K152838 | HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50JTN · Traditional | 11/24/2015SE |
| K102922 | Hardychrom MrsaJSO · Traditional | 05/04/2011SE |
| K103538 | Hardydisk Ast Ceftaroline, 30 Ug Model Z939JTN · Traditional | 12/17/2010SE |
| K093807 | Hardydisk Ast TELAVANCIN,30UGJTN · Traditional | 01/08/2010SE |
| K080019 | Hardydisk Ast Doripenem 10 UgJTN · Traditional | 01/29/2008SE |
| K062245 | Hardy Disk Ast Tigecycline 15 Ug, MODELZ936JTN · Traditional | 08/23/2006SE |
| K011384 | Hardydisk Novobiocin, 30MCG, Model Z883JTN · Traditional | 06/13/2001SE |
| K011385 | Hardkydisk Neomycin, 30 MCGJTN · Traditional | 05/18/2001SE |
| K011086 | Hardydisk Bacitracin, 10MCG, Model Z927JTN · Traditional | 04/26/2001SE |
| K003690 | Hardydisk SulfisoxazoleJTN · Traditional | 01/25/2001SE |
| K003554 | Hardydisk Trimethoprim 5MCGJTN · Traditional | 01/19/2001SE |
| K003556 | Hardydisk Amoxicillin/Clavulanic Acid, 20/10MCGJTN · Traditional | 01/17/2001SE |
| K003686 | Hardydisk Ticarcillin/Clavulanic Acid, 85MCGJTN · Traditional | 01/12/2001SE |
| K003537 | Hardydisk Rifampin, 5MCGJTN · Traditional | 01/12/2001SE |
| K003536 | Hardydisk Nafcillin, 1 MCGJTN · Traditional | 01/12/2001SE |
| K003532 | Hardy Disk, Cefpodoxine, 10MCGJTN · Traditional | 12/13/2000SE |
| K002662 | Hardydisk Clindamycin, 2MCGJTN · Traditional | 11/02/2000SE |
| K002664 | Hardydisk Levofloxacin, 5MCGJTN · Traditional | 10/26/2000SE |
| K002661 | Hardydisk Cefotetan, 30MCGJTN · Traditional | 10/26/2000SE |
| K002660 | Hardydisk Lomefloxacin, 10MCGJTN · Traditional | 10/26/2000SE |
| K002369 | Hardydisk Gentamicin, 120MCGJTN · Traditional | 10/26/2000SE |
| K002367 | Hardy Disk Ceftizoxime, 30MCGJTN · Traditional | 10/26/2000SE |
| K002656 | Hardydisk Cefuroxime, 30MCGJTN · Traditional | 10/25/2000SE |
| K002368 | Hardydisk Streptomycin, 300MCGJTN · Traditional | 10/25/2000SE |
| K002663 | Hardydisk Netilmicin, 30MCGJTN · Traditional | 10/19/2000SE |
| K001728 | Hardy Disk Clarithromycin, 15MCGJTN · Traditional | 07/27/2000SE |
| K001487 | Hardydisk Cinoxacin, 100 MCGJTN · Traditional | 06/07/2000SE |
| K001490 | Hardydisk Cefonicid, 30 MCGJTN · Traditional | 06/01/2000SE |
| K001489 | Hardydisk Cefoperazone, 75 MCGJTN · Traditional | 06/01/2000SE |
| K000526 | Hardydisk, Cephalothin 30MCGJTN · Traditional | 04/13/2000SE |
| K000525 | Hardydisk Ofloxacin 5MCGJTN · Traditional | 04/07/2000SE |
| K000524 | Hardydisk, Cefotaxime 30MCGJTN · Traditional | 04/07/2000SE |
| K000509 | Hardydisk, Vancomycin 30MCGJTN · Traditional | 04/07/2000SE |
| K000440 | Hardydisk Ceftriaxone 30MCGJTN · Traditional | 04/07/2000SE |
| K000272 | Hardydisk, NitrofurantoinJTN · Traditional | 04/07/2000SE |
| K000271 | Hardydisk, Sulfa/TrimethJTN · Traditional | 04/07/2000SE |
| K000268 | Hardydisk, Ampicillin, 10MCGJTN · Traditional | 04/07/2000SE |
| K000261 | Hardydisk, Piperacillin/Tazobactam, 110MCGJTN · Traditional | 04/07/2000SE |
| K000305 | Hardydisk, Cefoxitin, 30MCGJTN · Traditional | 03/31/2000SE |
| K000304 | Hardydisk, Tetracycline 30MCGJTN · Traditional | 03/29/2000SE |
| K000302 | Hardy Disk, Penicillin, 10 UnitsJTN · Traditional | 03/24/2000SE |
| K000259 | Hardydisk, Ceftazidime, 30MCGJTN · Traditional | 03/21/2000SE |
| K000258 | Hardydisk, Ciprofloxacin, 5MCGJTN · Traditional | 03/21/2000SE |
| K000203 | Hardydisk, Kanamycin, 30MCGJTN · Traditional | 03/21/2000SE |
| K000181 | Hardydisk, Carbenicillin, 100MCGJTN · Traditional | 03/02/2000SE |
| K000175 | Hardydisk Ticarillin 75MCGJTN · Traditional | 03/02/2000SE |
| K000201 | Hardydisk, Streptomycin 10MCGJTN · Traditional | 02/29/2000SE |
| K000182 | Hardydisk Tobramycin, 10MCGJTN · Traditional | 02/29/2000SE |
| K000130 | Hardydisk, Nalidixic Acid, 30MCGJTN · Traditional | 02/29/2000SE |
| K000183 | Hardydisk, Piperacillin, 100MCGJTN · Traditional | 02/28/2000SE |
| K000128 | Hardydisk, Cefazolin, 30MCGJTN · Traditional | 02/18/2000SE |
| K994134 | Hardydisk Oxacillin, 1MCGJTN · Traditional | 02/17/2000SE |
| K000022 | Hardydisk Cefamandole, 30MCGJTN · Traditional | 02/17/2000SE |
| K994150 | Hardydisk Norfloxacin, 10MCGJTN · Traditional | 02/16/2000SE |
| K994135 | Hardydisk Erythromycin, 15MCGJTN · Traditional | 02/16/2000SE |
| K994212 | Hardydisk Mezlocillin 75MCGJTN · Traditional | 02/15/2000SE |
| K994129 | Hardydisk Cefixime, 5MCGJTN · Traditional | 02/11/2000SE |
| K994091 | Hardydisk Gentamicin, 10MCGJTN · Traditional | 02/11/2000SE |
| K994089 | Hardydisk Chloramphenicol, 30MCGJTN · Traditional | 02/11/2000SE |
| K994046 | Hardydisk Cefaclor 30MCGJTN · Traditional | 02/01/2000SE |
| K994132 | Hardydisk Imipenem, 10MCGJTN · Traditional | 01/18/2000SE |
| K994067 | Hardy Disk Ampicillin/SulbactamJTN · Traditional | 01/14/2000SE |
| K994063 | Hardydisk Aztreonam, 30MCGJTN · Traditional | 01/14/2000SE |
| K994051 | Hardydisk Doxycycline, 30MCGJTN · Traditional | 01/10/2000SE |
| K993993 | Hardydisk Amikacin 30MCGJTN · Traditional | 12/27/1999SE |
| K993994 | Hardydisk Azithromycin 15MCGJTN · Traditional | 12/21/1999SE |
| K993812 | CVM Transport, Model R96,VIRAL Transport, Model R99, CVM Transport Kit, Model R96 K…JSM · Traditional | 12/21/1999SE |
| K964560 | Bhi W/Vancomycin AgarJSO · Traditional | 01/15/1997SE |
| K960075 | Chromagar CandidaJXC · Traditional | 08/02/1996SE |
| K955451 | CVM TransportJSM · Traditional | 07/22/1996SE |
| K961191 | ColiscreenJTO · Traditional | 06/17/1996SE |
| K960996 | M. Cat Butyrate DiskJTO · Traditional | 04/18/1996SE |
| K951754 | Culture Media, Antimicrobial Susceptibility TestJSO · Traditional | 10/16/1995SE |
| K941110 | ParakitLKS · Traditional | 05/17/1994SE |
| K934331 | Thayer Martin, Modified Pill PocketJTY · Traditional | 12/21/1993SE |
| K934330 | TransgrowJTY · Traditional | 12/17/1993SE |
| K931865 | Pyr Test KitJTO · Traditional | 12/15/1993SE |
| K931864 | Martin Lewis with LinocmycinJTY · Traditional | 12/15/1993SE |
| K931862 | Ninhydrin ReagentJTO · Traditional | 06/15/1993SE |
| K931414 | Catalase ReagentJTO · Traditional | 05/12/1993SE |
| K930693 | OxystripJTO · Traditional | 05/12/1993SE |
| K931530 | Bile Spot ReagentJTN · Traditional | 05/11/1993SE |
| K931413 | Ferric Chlorid Reagent, 10%JTO · Traditional | 05/11/1993SE |
| K930720 | Vogues-Proskauer Reagent a & BJTO · Traditional | 04/23/1993SE |
| K930718 | Indole Spot & Indole Kovacs ReagentJTO · Traditional | 04/23/1993SE |
| K930717 | Nitrate Reagents a, B and CJTO · Traditional | 04/23/1993SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2887-2026 Class II | HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (FDC30)…Due to incorrect cartridges include in affected products that there is the potential for false-susceptible… | 06/08/2026Open, Classified |
| Z-2041-2025 Class II | HardyCHROM CRE, selective and differential culture medium for antimicrobial…Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella… | 05/06/2025Open, Classified |
| Z-1835-2021 Class II | Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism… | 04/16/2021Terminated |
| Z-0919-2021 Class II | Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698…Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should… | 12/21/2020Terminated |
| Z-0655-2021 Class II | Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box…There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport… | 10/23/2020Terminated |
| Z-0441-2021 Class III | Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling… | 10/06/2020Terminated |
| Z-2298-2020 Class II | HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium…False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213)… | 11/14/2019Terminated |
| Z-2146-2016 Class II | QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains…Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper… | 05/24/2016Terminated |
| Z-1571-2016 Class II | Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by…Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the… | 03/21/2016Terminated |
| Z-0470-2016 Class II | FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria…The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum… | 11/18/2015Terminated |
| Z-2463-2015 Class II | HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm…Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the… | 07/09/2015Terminated |
| Z-2279-2015 Class II | Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box…Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with… | 06/26/2015Terminated |
| Z-2278-2015 Class II | Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20…Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with… | 06/26/2015Terminated |
| Z-2277-2015 Class II | Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10…Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with… | 06/26/2015Terminated |
| Z-2276-2015 Class II | Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged:…Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with… | 06/26/2015Terminated |
| Z-2275-2015 Class II | Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10…Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with… | 06/26/2015Terminated |
| Z-2274-2015 Class II | Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20…Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with… | 06/26/2015Terminated |
| Z-2273-2015 Class II | Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate…Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with… | 06/26/2015Terminated |
| Z-2192-2015 Class II | HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type:…Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance. | 06/24/2015Terminated |
| Z-1444-2015 Class II | Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat…The firm is recalling HardyCHROM SS, Cat. no. G327 Lot no. 15037 due to a report of possible lack of color… | 03/04/2015Terminated |