The Recall Desk

Manufacturer

Hardy Diagnostics

20 recalls in our database name Hardy Diagnostics as the manufacturing or recalling firm.

What the numbers show

Total
20
Critical
0
Severe
2
Most recent
2026-08-12

Of the 20 recalls from Hardy Diagnostics we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (10%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–20 of 20

  • HighFDA (Devices)·Z-2887-2026·2026-08-12

    HardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges

    Hardy Diagnostics is recalling HardyDisk AST Cefiderocol 30µg (Lot 543461) because incorrect cartridges may cause inaccurate susceptibility testing results.

    Product
    HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2041-2025·2025-07-09

    HardyCHROM CRE Culture Medium Recalled for Quality Control Failure

    Hardy Diagnostics is recalling HardyCHROM CRE culture medium (Catalog No. G323) distributed across 22 US states and Puerto Rico. The product failed quality control testing due to breakthrough growth of Klebsiella pneumoniae.

    Product
    HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-1835-2021·2021-06-16

    Medical microscope slide stainer recalled due to defective pump tubing

    Hardy Diagnostics is recalling the Quickslide GramPro 1 Automated Gram Stanier due to defective tubing in the pump mechanism that could cause device malfunction.

    Product
    Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0919-2021·2021-02-03

    Hardy Diagnostics Recalls Brain Heart Infusion Agar Plates Due to Contamination

    Hardy Diagnostics is recalling specific lots of Brain Heart Infusion Agar plates because they failed to inhibit Staphylococcus aureus as required.

    Product
    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
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0655-2021·2020-12-30

    Hardy Diagnostics Recalls Viral Transport Media Due to Contamination Risk

    Hardy Diagnostics is recalling Viral Transport Media due to potential contamination that may compromise COVID-19 test detection.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0441-2021·2020-11-18

    Hardy Diagnostics Recalls Strep B Carrot Broth Due to Incorrect Expiration Date

    Hardy Diagnostics is recalling Strep B Carrot Broth One-Step units because the outer box displays an incorrect expiration date of 2021-11-10 instead of 2020-11-10.

    Product
    Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-2298-2020·2020-06-17

    HardyCHROM MRSA Recall for False Positive Results

    Hardy Diagnostics is recalling HardyCHROM MRSA kits because they may produce false positive results for methicillin-susceptible Staphylococcus aureus.

    Product
    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
    Category
    Medical Device
    Distribution
    15 states
  • SevereFDA (Devices)·Z-2146-2016·2016-07-20

    Hardy Diagnostics Recalls QuickSlide MGS-80 Gram Stainers Due to Discrepant Results

    Hardy Diagnostics is recalling 25 QuickSlide MGS-80 and GramPRO-80 automated Gram stainers because they may produce discrepant culture and Gram stain results, potentially leading to misdiagnosis or improper patient treatment.

    Product
    QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1571-2016·2016-05-04

    Hardy Diagnostics Recalls GBS Detect Test Kits Due to Performance Failure

    Hardy Diagnostics is recalling GBS Detect test kits because product deterioration causes poor hemolytic reactions, potentially leading to inaccurate detection of Group B Streptococcus.

    Product
    Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0470-2016·2015-12-30

    Hardy Diagnostics Recalls FB Broth Due to Potential Contamination

    Hardy Diagnostics is recalling FB Broth (Lot 15231) because of potential Burkholderia fungorum contamination. The product was distributed in California, Wisconsin, Maryland, and Utah.

    Product
    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.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2463-2015·2015-09-02

    Hardy Diagnostics Recalls HardyCHROM MRSA In Vitro Diagnostic Plates

    Hardy Diagnostics is recalling HardyCHROM MRSA plates due to a potential quality control issue involving the MSSA strain.

    Product
    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
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2274-2015·2015-08-05

    Hardy Diagnostics Recalls Multiple Clinical Culture Media Due to Lack of Clearance

    Hardy Diagnostics is recalling several clinical culture media products, including BHI with Ciprofloxacin, because they lack FDA 510(k) clearance.

    Product
    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 sampl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2275-2015·2015-08-05

    Hardy Diagnostics Recalls MDR Acinetobacter and Other Media for Lack of Clearance

    Hardy Diagnostics is recalling MDR Acinetobacter and other diagnostic media because they lack FDA 510(k) clearance.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2278-2015·2015-08-05

    Hardy Diagnostics Recalls Multiple Microbiology Media Due to Lack of Clearance

    Hardy Diagnostics is recalling several microbiology media products, including BEA Broth with Vancomycin, because they lack FDA 510(k) clearance.

    Product
    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 r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2277-2015·2015-08-05

    Hardy Diagnostics Recalls Multiple Microbiology Media Due to Lack of 510(k) Clearance

    Hardy Diagnostics is recalling several microbiology media products, including BEA Agar with VGA, because they lack FDA 510(k) clearance.

    Product
    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).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2273-2015·2015-08-05

    Hardy Diagnostics Recalls MacConkey Agar and Other Media for Lack of Clearance

    Hardy Diagnostics is recalling specific lots of MacConkey Agar and other diagnostic media because they lack FDA 510(k) clearance.

    Product
    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 s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2276-2015·2015-08-05

    Hardy Diagnostics Recalls Multiple Microbiological Media Due to Lack of 510(k) Clearance

    Hardy Diagnostics is recalling several microbiological media products, including BEA Agar with Vancomycin, because they lack FDA 510(k) clearance.

    Product
    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 vanco
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2279-2015·2015-08-05

    Hardy Diagnostics Recalls VRE Broth and Other Media for Lack of Clearance

    Hardy Diagnostics is recalling VRE Broth and other diagnostic media because they lack FDA 510(k) clearance. The products were distributed in the U.S. and Canada.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2192-2015·2015-07-29

    Hardy Diagnostics Recalls HardyCHROM VRE Agar Due to Lack of Clearance

    Hardy Diagnostics is recalling HardyCHROM VRE Agar because it lacks FDA 510(k) clearance. The product was distributed to one customer in South Carolina.

    Product
    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.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1444-2015·2015-04-22

    Hardy Diagnostics Recalls HardyCHROM SS Agar Due to Color Development Issue

    Hardy Diagnostics is recalling HardyCHROM SS Agar (Lot 15037) due to a report of possible lack of color development in Shigella organisms.

    Product
    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 isolati
    Category
    Medical Device
    Distribution
    6 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Hardy Diagnostics

American health care company

Official website

Source: Wikidata (Q5656564), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.