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Mercedes Medical, Inc. recalls Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.
Recalled July 21, 2021 · FDA recall Z-2066-2021 · Mercedes Medical
Hazard
No 510(k) clearance · FDA Class II
Units
6,250 boxes MTM-04 with swab and 5,461 boxes MTM-04 tube only
Sold at
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, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, Washington, Wisconsin, and Puerto Rico. The country of Bahamas. Government distribution was made but no military distribution.
Description
No 510(k) clearance
Product
Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.
Manufacturer(s)
Mercedes Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →