Home › STANBIO LABORATORY, L.P. › STAT-Site M B-HB Strips

STAT-Site M B-HB Strips

STANBIO LABORATORY, L.P. · Model 401010 · UDI-DI 00657498000090

JIN Prescription

510(k) clearances

187

Adverse events (1 deaths)

Recalls

102

Facilities

Description

The STAT-Site® M β-HB Test is intended for the quantitative determination of the ketone body β-Hydroxybutyrate in serum or plasma using the STAT-Site® M β-HB Analyzer (Catalog #400400). The STAT-Site® M β-HB Test may be used with adults, infants, and children. For laboratory use only.

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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.