Alere San Diego, Inc. recalls Fisher Scientific Sure-Vue Urine hCG Strip

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

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;

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 network, notify them of this Field Corrective Action and provide them with a copy of this letter. 3) Retain this letter for your records. 4) Acknowledge receipt of this letter. Your organization s reply provides us with the necessary documentation to monitor the effectiveness of the field action notification. If you have questions regarding this information, U.S. Customers please contact the firm's Technical Services at 877-308-8289

• FDA enforcement recordOfficial FDA database entry for Z-3273-2026
• FDA 510(k) clearance · K993203The device's official FDA premarket clearance record
• FDA device classification · JHIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1155The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Alere San Diego, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.