Alere San Diego, Inc. recall (Class II): Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter I…
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. Product: Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025; Henry Schein One Step+ hCG Combo test in Serum or Urine, Model/ Part: FHC-202/9004075; Alere hCG Combo Cassette (25mIU/mL) in Urine (CLIA Waived) or Serum, Model/ Part: FHC-202/92225; Pro Advantage By NDC Urine/Serum Pregnancy Cassette Device, Model/ Part: FHC-202/P080021
- Published by source
- 2026-10-07
- First seen by Reality Radar
- 2026-10-20
- Last verified
- 2026-10-20
Affected
- Manufacturer
- Alere San Diego, Inc.
- Products
- Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025; Henr
Whether your exact unit is affected depends on the model, serial number and region in the official notice.
What the official notice says
Risk: Class II: hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Is this affecting you?
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Sources
- openFDA Recall Enforcement Reports Tier A · official published 2026-10-07
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