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Updated 2026-10-07

Alere San Diego, Inc. recalls Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/2

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Recalled Product

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 Cassette (25mIU/mL) in Urine, Model/ Part: FHC-102/92217; Cardinal Health hCG Cassette Rapid test CLIA Waived, Model/ Part: FHC-102/B1077-22; Medline HCG Pregnancy Test Cassette, Model/ Part: FHC-102/MPH12025HCG; Pro Advantage By NDC Urine Pregnancy Cassette Device, Model/ Part: FHC-102/P080063;

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 23900526/00613647000526/1155811105, 2018-01-15; 9004074/10304040024116/1155875704, 2014-06-09; 9004073/10304040024109/1155875704, 2014-06-09; 92217/10815845020109/1156015703, 07/16; B1077-22/20885380020251/1155904704, 9/2014; MPH12025HCG/10888277191877/1156093302, 2015-03-20; P080063/M220P0800633/40001853, 2023-03-30

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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