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Molecular Transport Media (MTM) 2ml
A. L. B. LUZ · Model MEI00218 · UDI-DI 07898996204648
QBD
Prescription
1
510(k) clearances
0
Adverse events
7
Recalls
24
Facilities
Description
The Molecular Transport Media is intended for the stabilization, transportation, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS COV-2 virus RNA. These devices can be used for the collection transport and storage of specimens at 15-35 °C. Specimens collected and stored in a Molecular Transport Media are suitable for use with 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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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.