United StatesDFI Co., Ltd.’s One Step 10A in vitro diagnostic test and six other in vitro diagnostic tests (One Step UTI REF 3374; One Step pH REF 31I4P; QUCARE Total Cholesterol REF 6407; Uric Acid REF 31H0P; One Step K REF 81A4; One Step P REF 8194) are being recalled; affected units are identified by the listed UDIs and lots. The firm recalled the devices because they were distributed without required FDA premarket clearance or approval and they were distributed worldwide, including US distribution in Florida and Pennsylvania and in England.
What's being recalled
One Step 10A in vitro diagnostic test
One Step UTI in vitro diagnostic test REF: 3374
One Step pH in vitro diagnostic test REF: 31I4P
QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
Uric Acid in vitro diagnostic test REF: 31H0P
One Step K in vitro diagnostic test REF: 81A4
One Step P in vitro diagnostic test REF: 8194
Recalling firm: DFI Co., Ltd., Gimhae, Korea (the Republic of).
How to identify it
UDI: 08806141303497/ Lot: 241023, 250305, 250415, 250527, 250625, 250905 UDI: 08806141303480/ Lot: 241023, 250625, 250905 UDI: 08806141303060/ Lot: 250305, 250415, 250509, 250625, 250905 UDI: 08806141303060/ Lot: BS032501, BS042502, BS062501, BS062502, BS082501 UDI: 08806141303077/ Lot: 241023, 250415, 250509, 250617, 250905 UDI:08806141302650/ Lot: 241023, 250625, 250905 UDI:08806141302025/ Lot: 241023, 250527, 250905
The hazard
The devices were distributed without required FDA premarket clearance or approval.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)