Class II — Alere San Diego, Inc.
| Recalling firm | Alere San Diego, Inc. |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 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; |
| Quantity | 13,256,075 |
| 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, Ireland, Spain, Portugal, New Zealand, Hong Kong, Australia, Papua New Guinea, Fiji, Guam, Sweden. |
| Initiated | 2026-08-20 |
| Classified | 2026-09-25 |
| Recall number | Z-3273-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-14. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Alere San Diego, Inc. (Z-3273-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-14. https://regwarden.com/recall/99409/
Alerts for Alere San Diego, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.