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U.S. Department of Health and Human Services

Class 2 Device Recall One Step K

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 Class 2 Device Recall One Step Ksee related information
Date Initiated by FirmApril 02, 2026
Date PostedMay 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2087-2026
Recall Event ID 98739
Product Classification Nitroprusside, ketones (urinary, non-quant.) - Product Code JIN
ProductOne Step K in vitro diagnostic test REF: 81A4
Code Information UDI:08806141302650/ Lot: 241023, 250625, 250905
FEI Number 3005841640
Recalling Firm/
Manufacturer		 DFI Co., Ltd.
388-25 Gomo-Ro
Jillye-Myeon
Gimhae Korea (the Republic of)
For Additional Information ContactYongae Park
55-3461882
Manufacturer Reason
for Recall		The devices were distributed without required FDA premarket clearance or approval.
FDA Determined
Cause 2		No Marketing Application
ActionOn April 2, 2026 Dream Future Innovation (DFI Co., Ltd.) issued a Urgent Medical Device Recall Notification to affected consignees via E. Mail. DFI ask consignees to take the following actions: 4.1 Distribution required Actions 1) Immediate Discontinuation: Immediately stop the use and distribution of the Products. 2) Inventory Quarantine: Quarantine all remaining inventory in a safe place and attach a NOT FOR SALE label. 3) Reply to Acknowledgement: Please fill out the attached Recall Acknowledgement Report and return it within 10 business days of receiving this notice 4) Sub-distributor Notification: Immediately notify all sub-distributors or end customers receiving Products. 4.2 End Customer required Actions 1) Stop using the product immediately. 2) Do not give or sell the product to anyone else. 3) Follow the instructions below regarding destruction or disposal. 4) Submit your refund / confirmation request as instructed. < Destruction / Disposal Instructions > To prevent accidental use, please cut the unused test strip(s) in half. After cutting the strips in half, please dispose of the destroyed components in accordance with your local municipal waste regulations
Quantity in Commerce761 units
DistributionWorldwide - US Nationwide distribution in the states of FL, PA and the country of England.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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