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STAT-Site WB B-Ketone Test Strips

STANBIO LABORATORY, L.P. · Model 7020-025 · UDI-DI 00657498002230

JIN Prescription

510(k) clearances

187

Adverse events (1 deaths)

Recalls

102

Facilities

Description

The EKF Diagnostics STAT-Site WB B-Ketone Test Strip, when used together with the EKF Diagnostics STAT-Site WB Dual Analyte Measurement System, is for multiple patient use in professional healthcare settings. It is intended for use by professionals in testing with capillary and venous whole blood samples. It should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.

Recalls

Date	Firm	Reason
2026-04-02	DFI Co., Ltd.	The devices were distributed without required FDA premarket clearance or approval.
2025-11-22	Changchun Wancheng Bio-Electron Co., Ltd.	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; devices may cause fa
2023-10-02	Stanbio Laboratory, LP	Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the sta
2023-05-22	Universal Meditech Inc.	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri
2023-05-22	Universal Meditech Inc.	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri
2022-03-08	MEDLINE INDUSTRIES, LP - Northfield	Product was improperly store which may cause a delay in results.
2021-07-12	Stanbio Laboratory, LP	Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
2021-07-12	Stanbio Laboratory, LP	Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
2021-07-12	Stanbio Laboratory, LP	Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
2021-07-12	Stanbio Laboratory, LP	Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.