Mercedes Medical recalls Lingen SAMPLE Disposable Virus Sampling Kits with no FDA 510(k) clearance. Affected kits may not be safe for medical use. Consumers should contact the company for details.
No 510(k) clearance
Mercedes Medical is recalling Lingen SAMPLE Disposable Virus Sampling Kits that lack FDA 510(k) clearance. This means the kits may not be safe for medical use, potentially leading to health risks if used improperly.
The kits lack FDA 510(k) clearance, meaning they have not been approved for medical use. This could lead to improper testing results or health risks if used without proper safety standards.
Healthcare workers and individuals using these kits for virus testing may be affected. Those with the specific model numbers and lots are most at risk.
Check for the model numbers SAM ENI MTM-04 or SAM ENI MTM04TUBE on the packaging. The kits contain 2 tubes and 2 swabs or 1 tube per pack.
Reach out to Mercedes Medical for specific instructions on how to handle the recalled kits.
The kits lack FDA 51:0(k) clearance, meaning they have not been approved for medical use.
Contact Mercedes Medical for specific instructions on how to handle the recalled kits.
The kits may not be safe for medical use due to lack of FDA clearance, potentially leading to health risks.
We’ve drafted a message you can send Mercedes Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2067-2021 — Mercedes Medical Mercedes Medical Hello, I own a Mercedes Medical that is covered by recall Z-2067-2021 from Mercedes Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
