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BioMAX

Spectrum Solutions L.L.C. · Model SDNA 1000 · UDI-DI 00850015033001

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The Spectrum Solutions BioMAX Specimen Collection device consists of a plastic tube designed for the collection of human saliva samples, a funnel, a cap with a stem flare, and a fluid chamber containing Spectrum’s inactivating media. Sample collection is conducted under the supervision of a Health care provider. The user deposits their saliva into the collection tube with the aid of the attached funnel, the user removes the funnel and replaces it with the cap. Upon twisting and closing the cap, the stabilizing solution is released into the tube and mixed with the saliva.

Recalls

Date	Firm	Reason
2022-08-09	DEWEI MEDICAL EQUIPMENT CO LTD	Products were distributed in the United States without FDA authorization or clearance.
2022-01-10	BASE 10 GENETICS INC	The product does not have 510(k) clearance.
2021-06-10	Mercedes Medical, Inc.	No 510(k) clearance
2021-06-10	Mercedes Medical, Inc.	No 510(k) clearance
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
2020-06-03	LONGHORN VACCINES AND DIAGNOSTIC	The tubes may have been delivered to some users without labels. Users may not be able to identify the tubes without these labels. If samples stored or transported in tubes are test

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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.