Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson CONSULT hCG ...
FDA Device Recall #Z-3273-2026 - Class II, August 20, 2026
Recall Summary
| Recall Number | Z-3273-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | August 20, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Alere San Diego, Inc. |
| Location | San Diego, CA |
| Product Type | Devices |
| Quantity | 13,256,075 |
Product Description
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;
Reason for Recall
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
Distribution Pattern
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.
Lot / Code Information
All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 23900527/00613647000588/1155811305, 2018-01-15; 5000/20612479202751/40008059, V05; 9004072/10304040024093/1155800504, 2014-06-09; 92211/10815845020093/40008089, 05/25; B-1077-21/20885380020244/40008054, 04/2025; MPH11025HCG/10884389191873/40006717, 6/2025; P080023/M220P0800233/40008087, 2025-05-09
Other Recalls from Alere San Diego, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3271-2026 | Class II | McKesson CONSULT hCG Urine Cassette, Model/ Par... | Aug 20, 2026 |
| Z-3272-2026 | Class II | Fisher Scientific Sure-Vue Serum/Urine hCG, Mod... | Aug 20, 2026 |
| Z-3274-2026 | Class II | Fisher Scientific Sure-Vue Urine hCG, Model/ Pa... | Aug 20, 2026 |
| Z-1702-2024 | Class II | Abbott Cholestech LDX Battery Kit, Model: 3LP65... | Mar 1, 2024 |
| Z-1508-2022 | Class II | The Cholestech LDX¿ System combines enzymatic m... | Jun 24, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.