Warning
DFI Co. Recalls One Step K in vitro diagnostic test REF: 81A4
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2087-2026Medical Device
DFI Co. Recalls One Step K in vitro diagnostic test REF: 81A4
DFI Co., Ltd. · Class II — Moderate Risk
Product Description
One Step K in vitro diagnostic test REF: 81A4
Reason for Recall
The devices were distributed without required FDA premarket clearance or approval.
FDA Classification
Class II — Moderate Risk
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.
Distribution
Worldwide - US Nationwide distribution in the states of FL, PA and the country of England.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database