Mercedes Medical recalls Lingen Disposable Virus Sampling Kit (MTM-04) due to lack of 510(k) clearance. All units are affected. No specific action steps provided in recall notice.
No 510(k) clearance
Mercedes Medical is recalling all Lingen Disposable Virus Sampling Kits (MTM-04, 40 tubes per box) because they lack FDA 510(k) clearance. This means the product hasn't been approved for use in the U.S. and may not be safe for medical use.
The product lacks FDA 510(k) clearance, meaning it hasn't been approved for medical use in the United States. This could lead to unsafe or ineffective medical procedures if used without proper regulatory oversight.
Healthcare professionals and labs using the Lingen Disposable Virus Sampling Kit (MTM-04) are affected. Those who have the product may be at risk if it's used without proper regulatory approval.
Check for the product name 'Lingen Disposable Virus Sampling Kit' and model number MTM-04. All lots are affected, so no specific lot numbers are safe.
Identify the product name and model number to confirm if it matches the recalled Lingen Disposable Virus Sampling Kit (MTM-04).
The recall states the product lacks FDA 510(k) clearance, meaning it has not been approved for medical use in the U.S. Safety cannot be confirmed without regulatory approval.
The recall notice does not specify any action steps, so no immediate action is required beyond checking if you have the product.
The recall indicates a lack of regulatory approval, but the notice does not describe specific injury risks or mechanisms.
We’ve drafted a message you can send Mercedes Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2066-2021 — Mercedes Medical Mercedes Medical Hello, I own a Mercedes Medical that is covered by recall Z-2066-2021 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.
