DFI Co., Ltd. recalls One Step K in vitro diagnostic test REF: 81A4
The devices were distributed without required FDA premarket clearance or approval.
Read the official notice →- Date
- 2026-05-13
- Country
- United States
- Brand
- DFI Co., Ltd.
- Product
- One Step K in vitro diagnostic test REF: 81A4
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of FL, PA and the country…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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