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AIMTAB KETONE TABLETS

GERMAINE LABORATORIES, INC · Model 13100 · UDI-DI 00695684131005

JIN Prescription

510(k) clearances

187

Adverse events (1 deaths)

Recalls

105

Facilities

Description

Tablet test for the detection of ketones (acetoacetic acid and acetone) in urine, serum, plasma, and whole blood. Similar to Acetest, trademark used by Bayer Healthcare, LLC.

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.