Medical Device Recall: Lingen Disposable Virus Sampling Kit, No 510(k) Clearance
The Lingen Disposable Virus Sampling Kit by Mercedes Medical was voluntarily recalled due to lacking FDA 510(k) clearance. The recall affected approximately 11,711 boxes 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 recall is classified as Moderate because no illnesses, injuries, or adverse events were reported in the source material. The recall was voluntary and precautionary in nature, initiated due to regulatory non-compliance (lacking 510(k) clearance) rather than a known product defect or safety hazard.
Plain-English summary
The Lingen Disposable Virus Sampling Kit, Item MTM-04, manufactured by Mercedes Medical, Inc., was voluntarily recalled. The product is designed as a disposable virus sampling kit with 40 tubes per box.
Approximately 11,711 boxes were recalled: 6,250 boxes containing the sampling kit with swab and 5,461 boxes containing only the sampling tube. All product lots were affected by the recall.
The product was distributed worldwide, including throughout the United States, Puerto Rico, and the Bahamas. Government distribution of the product occurred, though no military distribution was made.
The recall was initiated in June 2021 due to the product lacking FDA 510(k) clearance, which is required regulatory authorization before marketing medical devices in the United States. The recall was voluntarily initiated by Mercedes Medical, Inc., and was terminated in August 2023.
The recalled product
- Product
- Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.
- Manufacturer
- Mercedes Medical, Inc.
- Hazard
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.
See all 2 products in this recall →Related recalls
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