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First Sign®

HEMOSURE INC. · Model F2-CT25C · UDI-DI 00857338006330

JHI Prescription

510(k) clearances

3,857

Adverse events (1 deaths)

Recalls

110

Facilities

Description

First Sign hCG Pregnancy Urine/Serum Test Cassette (4mm); 25Pcs/Box for Hemosure

Recalls

Date	Firm	Reason
2026-08-20	Alere San Diego, Inc.	hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
2026-08-20	Alere San Diego, Inc.	hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
2026-08-20	Alere San Diego, Inc.	hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
2026-08-20	Alere San Diego, Inc.	hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
2024-08-23	Princeton Biomeditech Corp	This recall was initiated due to customer complaints of false negative of hCG test results when running patient urine samples. Use of the above listed product lot may result in fal
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
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
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

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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.