Official recall notice

FDA DeviceClass IINotable

Fisher Scientific Sure-Vue Urine hCG Strip Recall (Oct 2026)

Product: Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Part:FHC-101/5000; Henry Schein One Step+ hCG Urine Strip Test, Model/ Part: FHC-101/9004072; Alere hCG Dipstick (25mIU/mL) in Urine, Model/ Part: FHC-101/92211; Cardinal Health hCG Dipstick Rapid Test CLIA Waived, Model/ Part: FHC-101/B-1077-21; Medline hCG Pregnancy Test Strip, Model/ Part: FHC-101/MPH11025HCG; Pro Advantage by NDC Urine Pregnancy Test Strip, Model/ Part: FHC-101/P080023;

Recall date
2026-10-07
FDA class
Class II

Why it was recalled

Hazard

hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

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Product description

hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

Affected products

All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 23900527/00613647000588/1155811305, 2018-01-15; 5000/20612479202751/40008059, V05; 9004072/10304040024093/1155800504, 2014-06-09; 92211/10815845020093/40008089, 05/25; B-1077-21/20885380020244/40008054, 04/2025; MPH11025HCG/10884389191873/40006717, 6/2025; P080023/M220P0800233/40008087, 2025-05-09

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