One Step K Diagnostic Test Recall
One Step K in vitro diagnostic test REF: 81A4
Updated April 2, 2026
One Step K in vitro diagnostic test (model REF: 81A4) is being recalled because it was distributed without required FDA clearance. The safety and effectiveness of this test have not been reviewed by the FDA.
Is the DFI Co., Ltd. recalled? Yes. This product was recalled by FDA on April 2, 2026. Details below.
What is recalled
One Step K in vitro diagnostic test, model REF: 81A4, manufactured by DFI Co., Ltd.
Am I affected
You're affected if you have a One Step K diagnostic test with model number or reference "81A4" made by DFI Co., Ltd.
What to do right now
Stop using this test immediately. Contact your healthcare provider or the distributor to return it. Do not rely on results from this device.
The hazard
The devices were distributed without required FDA premarket clearance or approval.
Brands affected
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-Z-2087-2026
- Classification
- Class II
- Recalled
- April 2, 2026
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