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Mercedes Medical, Inc. recalls Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI
Recalled July 21, 2021 · FDA recall Z-2067-2021 · Mercedes Medical
Hazard
No 510(k) clearance · FDA Class II
Units
SAM ENI MTM04 - 58 packs; and SAM ENI MTM04TUBE - 49 packs
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 SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.
Manufacturer(s)
Mercedes Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →