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Limited official informationFDA Medical Device Enforcement ReportsRecall date: May 13, 2026

One Step K in vitro diagnostic test REF: 81A4

Full official product description

One Step K in vitro diagnostic test REF: 81A4 | Uric Acid in vitro diagnostic test REF: 31H0P | QUCARE Total Cholesterol in vitro diagnostic test REF: 6407 | One Step P in vitro diagnostic test REF: 8194 | One Step pH in vitro diagnostic test REF: 31I4P | One Step 10A in vitro diagnostic test | One Step UTI in vitro diagnostic test REF: 3374

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 3, 2026, 10:43 PM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

One Step K in vitro diagnostic test REF: 81A4; Uric Acid in vitro diagnostic test REF: 31H0P; plus 5 additional official variants listed below.

Identifiers to compare

  • UDI 08806141302650
  • UDI 08806141303077
  • UDI 08806141303060
  • UDI 08806141302025
  • UDI 08806141303497
  • UDI 08806141303480
  • Lot 241023
  • Lot BS032501
  • Lot 250305
  • Lot 250625
  • Lot 250905
  • Lot 250415
  • Lot 250509
  • Lot 250617
  • Lot BS042502
  • Lot BS062501
  • Lot BS062502
  • Lot BS082501
  • Lot 250527

7 official variants

Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
One Step K in vitro diagnostic test REF: 81A4UDI:08806141302650/ Lot: 241023, 250625, 250905761 unitsZ-2087-2026
Uric Acid in vitro diagnostic test REF: 31H0PUDI: 08806141303077/ Lot: 241023, 250415, 250509, 250617, 25090559815 unitsZ-2086-2026
QUCARE Total Cholesterol in vitro diagnostic test REF: 6407UDI: 08806141303060/ Lot: BS032501, BS042502, BS062501, BS062502, BS0825016398 unitsZ-2085-2026
One Step P in vitro diagnostic test REF: 8194UDI:08806141302025/ Lot: 241023, 250527, 2509051064 unitsZ-2088-2026
One Step pH in vitro diagnostic test REF: 31I4PUDI: 08806141303060/ Lot: 250305, 250415, 250509, 250625, 2509057860 unitsZ-2084-2026
One Step 10A in vitro diagnostic testUDI: 08806141303497/ Lot: 241023, 250305, 250415, 250527, 250625, 2509056533 unitsZ-2082-2026
One Step UTI in vitro diagnostic test REF: 3374UDI: 08806141303480/ Lot: 241023, 250625, 2509052423 unitsZ-2083-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

The devices were distributed without required FDA premarket clearance or approval.

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

  • : affectedSummary changed in the official record.