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HARDY DIAGNOSTICS · Model R64BX · UDI-DI 00816576024575

510(k) clearances

Adverse events

Recalls

Facilities

Description

Viral Transport Medium, 3ml, order by 100/ box For the collection and transport of specimens to the lab for the recovery/identification of viruses. Refrigerate after inoculation. For long term storage after inoculation, freeze at -70C. Do not moisten swab with the media prior to use. Refer to the IFU.

Recalls

Date	Firm	Reason
2023-10-02	Edge Biologicals Inc	Due to product outer packaging incorrectly labeled.
2022-07-12	Haimen Shengbang Laboratory Equipment Co. Ltd.	Distributed VTM outside of VTM Guidance and without clearance.
2022-07-12	Haimen Shengbang Laboratory Equipment Co. Ltd.	Distributed VTM outside of VTM Guidance and without clearance.
2022-07-12	Haimen Shengbang Laboratory Equipment Co. Ltd.	Distributed VTM outside of VTM Guidance and without clearance.

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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.