FDAClass IIJuly 21, 2021

Lingen Disposable Virus Sampling Kit recall

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

Why was Lingen Disposable Virus Sampling Kit recalled?

No 510(k) clearance

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots.

Product
Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.
Recalling firm
Mercedes Medical, Inc.
Quantity
6,250 boxes MTM-04 with swab and 5,461 boxes MTM-04 tube only
Distribution
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.
Recall date
July 21, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls