Medical device recall: Lingen SAMPLE Virus Sampling Kit lacks FDA clearance
Mercedes Medical voluntarily recalled Lingen SAMPLE Virus Sampling Kits due to lack of FDA 510(k) clearance. The recall affects units distributed nationwide and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or hospitalization. The recall is voluntary and precautionary in nature, initiated due to lack of 510(k) clearance—a regulatory compliance issue rather than reported harm.
Plain-English summary
Mercedes Medical, Inc. has recalled Lingen SAMPLE Disposable Virus Sampling Kits, including model SAM ENI MTM-04 (58 packs, containing 2 tubes and 2 swabs each) and SAM ENI MTM04TUBE (49 packs, containing 1 tube each). All lots of these products are included in the recall.
The recall was initiated because the product had not received FDA 510(k) clearance, a required authorization for marketing medical devices in the United States. This is a Class II recall, and Mercedes Medical voluntarily initiated the action on June 10, 2021.
The affected products were distributed worldwide, including across the United States (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) and the Bahamas. Government distribution occurred, but no military distribution.
Consumers and healthcare facilities in possession of these kits should cease use and contact Mercedes Medical for replacement or guidance. The FDA terminated this recall on August 14, 2023.
The recalled product
- 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
- Mercedes Medical, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Mercedes Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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