Medical device recalls Moderate risk

Mercedes Medical, Inc. recalls Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.

Recall date
June 10, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2066-2021
FDA classification
Class II
Brand / firm
Mercedes Medical, Inc.
Sold / distributed
Worldwide distribution - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Montana, North Carolina, Nebraska, N…

Why it was recalled

No 510(k) clearance

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.

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