QUCARE Total Cholesterol in vitro diagnostic tests without FDA premarket clearance are being recalled. Consumers should check product labels for lot numbers BS032501 to BS082501.
The devices were distributed without required FDA premarket clearance or approval.
QUCARE Total Cholesterol test kits (REF: 6407) were recalled because they were distributed without required FDA premarket clearance. This means the tests might not be safe or effective, but the recall does not specify immediate harm risks.
The tests were distributed without required FDA premarket clearance, meaning they might not meet safety and effectiveness standards. This could lead to inaccurate results or potential health risks if used for medical purposes without proper regulatory approval.
People who purchased QUCARE Total Cholesterol test kits with lot numbers BS032501 through BS082501 are affected. Those using these kits for medical testing may be at risk if the tests are not properly cleared by the FDA.
Check the product label for the reference number REF: 6407 and lot numbers BS032501, BS042502, BS062501, BS062502, or BS082501. The unique device identifier (UDI) is 08806141303060.
Look for the reference number REF: 6407 and lot numbers BS032501 to BS082501 on the test kit label.
The tests were distributed without required FDA premarket clearance or approval.
Check the product label for the reference number REF: 6407 and lot numbers BS032501, BS042502, BS062501, BS062502, or BS082501.
The recall record does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send QUCARE to request your refund or repair — edit it as you like.
Subject: Recall Z-2085-2026 — QUCARE QUCARE Hello, I own a QUCARE that is covered by recall Z-2085-2026 from QUCARE. 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.
