Reference notice · device
Alere San Diego, Inc. — Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074, FHC-102/9004073; Alere hCG Cas
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
San Diego, CA, US · Updated 9/25/2026, 12:00:00 AM UTC
Source: FDA — device enforcement reference