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ZHEJIANG GENE SCIENCE
ZHEJIANG GENE SCIENCE CO., LTD. · Model 2.0 mL/tube;100pcs/Tray, 15 Trays/Box · UDI-DI 06974679160768
1
510(k) clearances
0
Adverse events
7
Recalls
24
Facilities
Description
The Zhejiang GENE SCIENCE Co., Ltd. Sample Preservation Solution consists of a plastic, polypropylene screw-cap collection tube filled with non-sterile sample preservation medium. The tubes are pre-filled with either 2 mL (suitable for swabs with flocking length of 20-24mm) or 3 mL (suitable for swabs with flocking length of 24-30mm) of solution. The device is non-sterile, singe use.
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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Get your free API keyRead the docsData 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.