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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Mercedes Medical, Inc.: No 510(k) clearance

Agency Publication Date: July 12, 2021
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Affected Products

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

All lots.

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.

All lots.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88088
Status: Resolved
Manufacturer: Mercedes Medical, Inc.
Manufactured In: United States
Units Affected: 2 products (6,250 boxes MTM-04 with swab and 5,461 boxes MTM-04 tube only; SAM ENI MTM04 - 58 packs; and SAM ENI MTM04TUBE - 49 packs)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.