Recall Z-3272-2026 ยท JHI Visual, Pregnancy Hcg, Prescription Use
Alere San Diego, Inc.
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 Dev
| Date | Sep 25, 2026 (initiated Aug 20, 2026) |
| Status | Open, Classified |
| Reason | hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. |
| Root cause | Device Design |
| Action | On 8/20/2026, correction notices started being emailed to customers and distributors informing them to take the following actions: 1) In situations where an unexpected test result is obtained, consider all limitations, including peri-menopause that may result in low levels of hCG. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated, and an alternate confirmatory test that supports a timely clinical decision has been considered. 2) If you have forwarded affected products to other laboratories within your distribution |
| Quantity | 5,331,585 |
| Distribution | Worldwide - US Nationwide distribution including in the states of IL, PA, FL, GA, VA, NY, TN, AZ, ID, ND, WI, AL, LA, NJ,MT, NE, OH, PR, IN, MI, WY, MA, CA, TX, HI, KS, KY, AR, CO, NC, WA, IA, MN, OK, OR, NM, SC, GU, MD, NV, MS, WV, SD, VT, DE and the countries of United Kingdom, Canada, Italy, Irel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993065 | ACON COMBO PREGNANCY ACON Laboratories, Inc., Oct 8, 1999 |