Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Hardy Diagnostics with 110 510(k) clearances and 20 device recalls. The most recent is a device recall dated Jun 8, 2026: HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FD….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jun 8, 2026 | HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testClass II · Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resi | Device recalls |
| May 6, 2025 | HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323Class II · Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae. | Device recalls |
| Apr 16, 2021 | Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.Class II · Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the | Device recalls |
| Dec 21, 2020 | 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: 15Class II · Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been i | Device recalls |
| Oct 23, 2020 | Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic ceClass II · There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media for the | Device recalls |
| Oct 6, 2020 | Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499Class III · Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an e | Device recalls |
| Nov 14, 2019 | HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal coloniClass II · False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough | Device recalls |
| May 24, 2016 | QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systematically stains, rinses, decolorizes, and counter-stains the provClass II · Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patie | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
