Device recall: One Step 10A in vitro diagnostic test
Class II FDA enforcement event 98739. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
The devices were distributed without required FDA premarket clearance or approval.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
DFI Co., Ltd. started this device recall on 2 Apr 2026. The firm address in the FDA record is in Gimhae. FDA put the recall in Class II. FDA event 98739 has 7 product records. The first FDA enforcement report date is 13 May 2026. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
Recalling firm
DFI Co., Ltd., Gimhae, Korea (the Republic of).
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
7 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2082-2026 | One Step 10A in vitro diagnostic test | 6533 units | Class II | Ongoing | 13 May 2026 |
| Z-2083-2026 | One Step UTI in vitro diagnostic test REF: 3374 | 2423 units | Class II | Ongoing | 13 May 2026 |
| Z-2084-2026 | One Step pH in vitro diagnostic test REF: 31I4P | 7860 units | Class II | Ongoing | 13 May 2026 |
| Z-2085-2026 | QUCARE Total Cholesterol in vitro diagnostic test REF: 6407 | 6398 units | Class II | Ongoing | 13 May 2026 |
| Z-2086-2026 | Uric Acid in vitro diagnostic test REF: 31H0P | 59815 units | Class II | Ongoing | 13 May 2026 |
| Z-2087-2026 | One Step K in vitro diagnostic test REF: 81A4 | 761 units | Class II | Ongoing | 13 May 2026 |
| Z-2088-2026 | One Step P in vitro diagnostic test REF: 8194 | 1064 units | Class II | Ongoing | 13 May 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2026
- 572
- Share of these events in Class II
- 87%
- Product records in this event
- 7
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-2082-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 98739. https://recallregister.com/fda/ii/98739/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
- What quantity of product is in FDA event 98739?
- The event has 7 product records. The first record gives this quantity:
6533 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 87% of the 572 device events that started in 2026 are in Class II.