Class IIOngoingZ-2088-2026
DFI Co., Ltd. recalls One Step P in vitro diagnostic test REF: 8194
The devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd.May 13, 2026
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–3 of 3 recalls
Class IIOngoingZ-1484-2026
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
Siemens Healthcare Dia…NYMar 11, 2026
Class IIOngoingZ-1265-2026
Changchun Wancheng Bio-Electron Co., Ltd. recalls Vivoo Protein Test
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers;…
Changchun Wancheng Bio…Feb 11, 2026