Recall Z-3272-2026— Alere San Diego, Inc.

Name: FDA recall Z-3272-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-20

Class II · Ongoing

Class II FDA medical device recall by Alere San Diego, Inc., initiated 2026-08-20. It names one FDA 510(k) clearance: K993065. 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. Reason: hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result..

Recalling firm: Alere San Diego, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-08-20
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K993065 — ACON COMBO PREGNANCYACON Laboratories, Inc.·cleared 1999-10-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.