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HARDY DIAGNOSTICS · Model R99 · UDI-DI 00819398023818

JSM Prescription

510(k) clearances

583

Adverse events (1 deaths)

Recalls

Facilities

Description

Viral Transport Medium VTM, 3ml fill (swabs sold separately), order by the package of 20 Hardy Diagnostics Viral Transport Medium is recommended for the collection and transport of clinical specimens for the preservation of viral agents including, Influenza A, Influenza B, Adenovirus, and Echovirus from the collection site to the testing laboratory.

Recalls

Date	Firm	Reason
2024-06-20	Cepheid	Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing fal
2022-08-12	American Contract Systems, Inc.	Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	XXX
2022-05-02	American Contract Systems, Inc.	Affected products were assembled off-site by individuals who may not have been properly trained.
2022-05-02	American Contract Systems, Inc.	Affected products were assembled off-site by individuals who may not have been properly trained.
2021-03-18	Gentueri Inc	Medium showed visual turbidity and discoloration, potentially contaminating samples transported for testing.
2021-03-11	Krishe Inc	Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
2021-03-11	Krishe Inc	Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.