Hardy Diagnostics
Orcutt, CA, US
HARDY DIAGNOSTICS appears in FDA device records in Orcutt, CA. FDA records list 109 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 24 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Hardy Diagnostics carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Hardy Media Inc Dba Hardy Diagrecall
510(k) clearance history
Showing 50 of 109FDA records hold 109 510(k) clearances for Hardy Diagnostics between 1993 and 2026. The busiest year on record is 2000, with 49. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 12 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 4 |
| 1997 | 1 |
| 1999 | 3 |
| 2000 | 49 |
| 2001 | 9 |
| 2006 | 1 |
| 2008 | 1 |
| 2010 | 2 |
| 2011 | 1 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 5 |
| 2018 | 3 |
| 2019 | 4 |
| 2020 | 1 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 3 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260842 | HardyDisk AST Gepotidacin 10µg (GEP10) | JTN | Substantially Equivalent | |
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) | JTN | Substantially Equivalent | |
| K250956 | HardyDisk AST Gepotidacin 10µg (GEP10) | JTN | Substantially Equivalent | |
| K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) | JTN | Substantially Equivalent | |
| K233534 | Viral Transport Medium | JSM | Substantially Equivalent | |
| K241060 | HardyDisk AST Cefiderocol 30µg (FDC30) | JTN | Substantially Equivalent | |
| K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) | JTN | Substantially Equivalent | |
| K230827 | HardyDisk AST Rezafungin 5µg (RZF5) | JTN | Substantially Equivalent | |
| K193504 | HardyDisk AST Cefiderocol 30ug (FDC30) | JTN | Substantially Equivalent | |
| K192326 | HardyDisk AST Lefamulin 20µg (LMU20) | JTN | Substantially Equivalent | |
| K191931 | HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) | JTN | Substantially Equivalent | |
| K190553 | HardyCHROM CRE | JSO | Substantially Equivalent | |
| K183298 | HardyDisk AST Omadacycline 30µg (OMC30) | JTN | Substantially Equivalent | |
| K182357 | HardyDisk AST Eravacycline 20µg (ERV20) | JTN | Substantially Equivalent | |
| K181700 | HardyDisk AST Plazomicin 30ug (PLZ30) | JTN | Substantially Equivalent | |
| K173903 | Granada Medium | PQZ | Substantially Equivalent | |
| K172621 | HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) | JTN | Substantially Equivalent | |
| K171975 | HardyDisk AST Delafloxacin 5 µg (DLX5) | JTN | Substantially Equivalent | |
| K170586 | Strep B Carrot Broth One-Step | PQZ | Substantially Equivalent | |
| K170481 | Strep B Carrot Broth Kit | PQZ | Substantially Equivalent | |
| K170127 | HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 | JTN | Substantially Equivalent | |
| K160512 | HardyCHROM ESBL | JSO | Substantially Equivalent | |
| K152846 | HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40 | JTN | Substantially Equivalent | |
| K152838 | HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50 | JTN | Substantially Equivalent | |
| K102922 | HARDYCHROM MRSA | JSO | Substantially Equivalent | |
| K103538 | HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939 | JTN | Substantially Equivalent | |
| K093807 | HARDYDISK AST TELAVANCIN,30UG | JTN | Substantially Equivalent | |
| K080019 | HARDYDISK AST DORIPENEM 10 UG | JTN | Substantially Equivalent | |
| K062245 | HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936 | JTN | Substantially Equivalent | |
| K011384 | HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883 | JTN | Substantially Equivalent | |
| K011385 | HARDKYDISK NEOMYCIN, 30 MCG | JTN | Substantially Equivalent | |
| K011086 | HARDYDISK BACITRACIN, 10MCG, MODEL Z927 | JTN | Substantially Equivalent | |
| K003690 | HARDYDISK SULFISOXAZOLE | JTN | Substantially Equivalent | |
| K003554 | HARDYDISK TRIMETHOPRIM 5MCG | JTN | Substantially Equivalent | |
| K003556 | HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG | JTN | Substantially Equivalent | |
| K003686 | HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG | JTN | Substantially Equivalent | |
| K003537 | HARDYDISK RIFAMPIN, 5MCG | JTN | Substantially Equivalent | |
| K003536 | HARDYDISK NAFCILLIN, 1 MCG | JTN | Substantially Equivalent | |
| K003532 | HARDY DISK, CEFPODOXINE, 10MCG | JTN | Substantially Equivalent | |
| K002662 | HARDYDISK CLINDAMYCIN, 2MCG | JTN | Substantially Equivalent | |
| K002664 | HARDYDISK LEVOFLOXACIN, 5MCG | JTN | Substantially Equivalent | |
| K002661 | HARDYDISK CEFOTETAN, 30MCG | JTN | Substantially Equivalent | |
| K002660 | HARDYDISK LOMEFLOXACIN, 10MCG | JTN | Substantially Equivalent | |
| K002369 | HARDYDISK GENTAMICIN, 120MCG | JTN | Substantially Equivalent | |
| K002367 | HARDY DISK CEFTIZOXIME, 30MCG | JTN | Substantially Equivalent | |
| K002656 | HARDYDISK CEFUROXIME, 30MCG | JTN | Substantially Equivalent | |
| K002368 | HARDYDISK STREPTOMYCIN, 300MCG | JTN | Substantially Equivalent | |
| K002663 | HARDYDISK NETILMICIN, 30MCG | JTN | Substantially Equivalent | |
| K001728 | HARDY DISK CLARITHROMYCIN, 15MCG | JTN | Substantially Equivalent | |
| K001487 | HARDYDISK CINOXACIN, 100 MCG | JTN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2022807 | 2022807 | HARDY DIAGNOSTICS | 1430 WEST MCCOY LN., Orcutt, CA 93455 US | 2026 | and 22 more, listed in full below |
| 3009547954 | 3009547954 | Hardy Diagnostics | 429 S Pioneer Blvd, Springboro, OH 45066 US | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- SANAutomated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
- KKWBasic Fuchsin
- JSLCulture Media, Anaerobic Transport
- JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
- KZICulture Media, Enriched
- JTYCulture Media, For Isolation Of Pathogenic Neisseria
- JSCCulture Media, General Nutrient Broth
- JSECulture Media, Multiple Biochemical Test
- JSMCulture Media, Non-Propagating Transport
- JSHCulture Media, Non-Selective And Differential
- JSGCulture Media, Non-Selective And Non-Differential
- JSICulture Media, Selective And Differential
- JSJCulture Media, Selective And Non-Differential
- JSDCulture Media, Selective Broth
- JSFCulture Media, Single Biochemical Test
- LIBDevice, General Purpose, Microbiology, Diagnostic
- LKSDevice, Parasite Concentration
- JTODiscs, Strips And Reagents, Microorganism Differentiation
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- PQZGbs Culture Media, Selective And Differential
- PPMGeneral Purpose Reagent
- JXCKit, Screening, Yeast
- JTAMonitor, Microbial Growth
- LEBMounting Media
- JTLPlasma, Coagulase, Human, Horse And Rabbit
- LJGQuality Control Slides
- KPASlide Stainer, Automated
- KEWSlides, Microscope
- JCESolution, Isotonic
- KQCStains, Hematology
- JTSStains, Microbiologic
- JSKSupplement, Culture Media
- JTNSusceptibility Test Discs, Antimicrobial
- LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2887-2026 | HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii complex and Stenotrophomonas maltophilia to Cefiderocol, | Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome. | Class II | Open, Classified | |
| Z-2041-2025 | HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323 | Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae. | Class II | Open, Classified | |
| Z-1835-2021 | 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 within the unit. | Class II | Terminated | |
| Z-0919-2021 | Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml | Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited. | Class II | Terminated | |
| Z-0655-2021 | Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents | There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compromise the detection of COVID-19 by the final device used for testing. | Class II | Terminated | |
| Z-0441-2021 | Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499 | Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expiration date of 2020-11-10 | Class III | Terminated | |
| Z-2298-2020 | 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 | False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited. | Class II | Terminated | |
| Z-2146-2016 | QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide. | Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient. | Class II | Terminated | |
| Z-1571-2016 | Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus. | Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to product deterioration. | Class II | Terminated | |
| Z-0470-2016 | FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens. | The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination. | Class II | Terminated | |
| Z-2463-2015 | HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com | Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot. | Class II | Terminated | |
| Z-2279-2015 | Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting. | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. | Class II | Terminated | |
| Z-2278-2015 | Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes/box fill: 2ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. | Class II | Terminated | |
| Z-2277-2015 | Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE). | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. | Class II | Terminated | |
| Z-2276-2015 | Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vancomycin-resistant enterococci/group D streptococci, such as Enterococcus faecalis and E. faecium, from fecal and rectal cultures. | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. | Class II | Terminated | |
| Z-2275-2015 | Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii. | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. | Class II | Terminated | |
| Z-2274-2015 | Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Heart Infusion Broth with Ciprofloxacin, 1ug is for use as pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical samples. | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. | Class II | Terminated | |
| Z-2273-2015 | Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MacConkey Agar with Ciprofloxacin is used as a screening medium for the selective isolation of Ciprofloxacin-resistant E. coli from clinical samples. | Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth due to lack of 510(k) clearance. | Class II | Terminated | |
| Z-2192-2015 | HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening. | Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance. | Class II | Terminated | |
| Z-1444-2015 | Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2 to 8 degrees C. on receipt in dark A selective chromogenic medium for the primary screening isolation, and differentiation of Salmonella & Shigella spp. | The firm is recalling HardyCHROM SS, Cat. no. G327 Lot no. 15037 due to a report of possible lack of color development in Shigella organisms in the referenced lot. | Class II | Terminated | |
| Z-0078-2007 | HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates per sleeve, Hardy Diagnostics, Santa Maria, CA 93455 | Performance failure; the product is failing to show pigment development for E. coli 0157. | Terminated | ||
| Z-1451-06 | BHI Agar with Vancomycin, for in vitro diagnostic use. Catalog # G14, Lot# 06136 | This recall is being conducted due to the performance failure nearing the end of the product shelf life. | Terminated | ||
| Z-0542-04 | Nitrate Reagent A, Cat No. Z71, Lot 3338 Nitrate Reagent B, Cat No. A72, Lot 3338 | Mislabeled. | Terminated | ||
| Z-1076-03 | Blood Agar Plates, 5%, Lot 3155A. | Customers complained of bacterial contamination of lot A10-3155A. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Hardy Diagnostics edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain