Urine Test Recall: One Step UTI REF 3374
DFI Co., Ltd.'s One Step UTI in vitro diagnostic test REF 3374 is being recalled by the FDA. The devices were distributed without the required FDA premarket clearance or approval, with about 2,423 units distributed worldwide including the US (Florida and Pennsylvania) and England. The recall is associated with UDI 08806141303480 and lots 241023, 250625, 250905.
| Brand | DFI Co., Ltd. |
|---|---|
| Product | One Step UTI in vitro diagnostic test REF: 3374 |
| Reason | The devices were distributed without required FDA premarket clearance or approval. |
| Severity | moderate |
| Units affected | 761 |
| Distribution | Worldwide - US Nationwide distribution in the states of FL, PA and the country of England. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use the affected test kit.
- If you have the product, set it aside and contact the seller or distributor for guidance on disposal, return, or replacement.
- Check the recall details (UDI and lot numbers) and contact FDA or the seller for further information on refunds or next steps.
How to identify the recalled item
| Lot / date codes | UDI: 08806141303480/ Lot: 241023, 250625, 250905 |
|---|---|
| Lot / date codes | UDI:08806141302650/ Lot: 241023, 250625, 250905 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.