DFI Uric Acid Test Recall Issued
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DFI Co., Ltd. is recalling 59,815 units of its Uric Acid in vitro diagnostic test distributed without required FDA premarket clearance or approval.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 26, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
What Happened
The devices were distributed without required FDA premarket clearance or approval.
Which Products Are Affected
Uric Acid in vitro diagnostic test REF: 31H0P. UDI: 08806141303077. Lots: 241023, 250415, 250509, 250617, 250905. 59,815 units distributed worldwide with US distribution in FL and PA and to England. Recall number Z-2086-2026. Class II recall initiated April 2, 2026.
What You Should Do
Consumers should follow guidance from the recalling firm regarding the affected devices.
Why This Matters
This ongoing Class II recall affects diagnostic devices distributed in multiple regions without required regulatory clearance.
Source
FDA Enforcement Report, recall number Z-2086-2026, report date May 13, 2026.
Original source: FDA Official Notice ↗
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