Hardy Diagnostics

Complete recall history across all FDA and CPSC categories — 19 total recalls

Hardy Diagnostics appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (19)

FDA medical device enforcement actions by Hardy Diagnostics

Date Product Reason Class
May 6, 2025 HardyCHROM CRE, selective and differential culture medium for antimicrobial s... Identified lots failed incoming quality control testing. Lots exhibited break... Class II
Apr 16, 2021 Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer. Instruments were assembled and serviced using a defective lot of tubing, whic... Class II
Dec 21, 2020 Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 ... Complaints were received reporting of Staphylococcus aureus (ATCC 29213) brea... Class II
Oct 23, 2020 Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tub... There is a potential for contamination within Viral Transport Media. Use of ... Class II
Oct 6, 2020 Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499 Streptococcus culture medium contains an incorrect expiration date. The cultu... Class III
Nov 14, 2019 HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromoge... False Positive results due to the MSSA (methicillin-susceptible) strain Staph... Class II
May 24, 2016 QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systemat... Discrepant culture and gram stain results, which could potentially lead to mi... Class II
Mar 21, 2016 Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and det... Performance failure; poor hemolytic reaction of non or weakly hemolytic group... Class II
Nov 18, 2015 FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A f... The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potenti... Class II
Jul 9, 2015 HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container... Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potenti... Class II
Jun 26, 2015 Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart... Class II
Jun 26, 2015 Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate p... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart... Class II
Jun 26, 2015 Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monop... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart... Class II
Jun 26, 2015 Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x10... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart... Class II
Jun 26, 2015 Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube p... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart... Class II
Jun 26, 2015 Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate p... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart... Class II
Jun 26, 2015 Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged:... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart... Class II
Jun 24, 2015 HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 ... Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clea... Class II
Mar 4, 2015 Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shi... The firm is recalling HardyCHROM SS, Cat. no. G327 Lot no. 15037 due to a rep... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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