QUCARE Total Cholesterol in vitro Diagnostic Test Recalled
DFI Co., Ltd. is recalling QUCARE Total Cholesterol in vitro diagnostic test devices because they were distributed without required FDA premarket clearance or approval.
What this means for you
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: FDA Class II recall for a device distributed without premarket clearance. The source text does not report any illness, injury, or malfunction, only unauthorized distribution. This is a regulatory compliance issue without reported adverse health consequences.
Plain-English summary
DFI Co., Ltd. is recalling QUCARE Total Cholesterol in vitro diagnostic test (REF: 6407) because the devices were distributed without required FDA premarket clearance or approval.
The recalled devices were distributed nationwide in Florida and Pennsylvania, and to England. The affected lot numbers are BS032501, BS042502, BS062501, BS062502, and BS082501 (UDI: 08806141303060).
If you have one of these devices, discontinue use and contact DFI Co., Ltd. for instructions on return or replacement. Do not rely on results from these devices without consulting your healthcare provider about your cholesterol status.
The recalled product
- Product
- QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
- Manufacturer
- DFI Co., Ltd.
- Affected units
- 6,398
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 (5)
- UDI: 08806141303060/ Lot: BS032501
- BS042502
- BS062501
- BS062502
- BS082501
Distribution
Part of a larger recall action
This product is one of 7 recalled by DFI Co., Ltd. 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.
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