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Sample Preservative Fluid

Hangzhou Bioer Technology Co., Ltd. · Model BSC82X1-A1 · UDI-DI 06973843228914

QBD Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Sample Preservative Fluid is intended for the stabilization, transportation, and inactivation of infectious, unprocessed, upper respiratory specimens suspected of containing Influenza A virus. Specimens transported in the Sample Preservative Fluid are stable refrigerated (2-8°C) and at room temperature (20-25°C). The Sample Preservative Fluid is suitable for use with compatible legally marketed molecular diagnostic devices.

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.