Facility

Hardy Diagnostics

14 recall(s) on record — most severe on record: Class II.

Key facts

14recalls · worst Class II

3inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3009547954
Establishment type	Manufacture Medical Device
Location	429 S Pioneer Blvd Springboro, OH, US 45066
Registration status	Active · expires 2026
Parent company	HARDY DIAGNOSTICS (owner-operator 2022807)
Brand names	TransPRO; Viral Transport Medium

Activity by year

Recalls (14)
Inspections (3)

Devices registered here (1)

Culture Media, Non-Propagating Transport
Product code JSM (opens in a new tab) · Class I · Microbiology · 21 CFR 866.2390

Recalls & enforcement

20261 record

Class IIOngoing2026-06-08
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, prolonge…

20251 record

Class IIOngoing2025-05-06
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.

20211 record

Class IITerminated2021-04-16
Instruments were assembled and serviced using a defective lot of tubing, which is part of the pump mechanism within the unit.

20203 records

Class IITerminated2020-12-21
Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
Class IITerminated2020-10-23
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 IIITerminated2020-10-06
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

20191 record

Class IITerminated2019-11-14
False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (ATCC 29213) breakthrough when this strain should have been inhibited.

20162 records

Class IITerminated2016-05-24
Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improper treatment of a patient.
Class IITerminated2016-03-21
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.

20155 records

Class IITerminated2015-11-18
The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.
Class IITerminated2015-07-09
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 IITerminated2015-06-26
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 o…
Class IITerminated2015-06-24
Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.
Class IITerminated2015-03-04
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.

FDA inspections (3)

NAI2024-10-10
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2022-09-19
No Action Indicated · Compliance: Devices
NAI2017-11-08
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Hardy Diagnostics (FEI 3009547954) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009547954-hardy-diagnostics/

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