Device recall

McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210; Fisher Scientific Sure-Vue Serum/Urine¿hCG-STAT, Model/ Part: FHC-A202/23900531, FHC-A202/23900530; McKesson CONSULT Diagnostics hCG Urine Cassette, Model/ Part: FHC-A202/5002; Alere hCG Combo Cassette (20/10 mIU/mL) for Urine or Serum, Model/ Part: FHC-A202/92215; Cardinal Health hCG Combo Rapid Test Serum or Urine, Model/ Part: FHC-A202/B-1077-23; Medline hCG Combo Pregnancy Test Cassette, Model/ Part: FHC-A202/MPH22025HCG;

FDA recall source

Recall number: Z-3271-2026
Event id: 99409
Status: Ongoing
FDA classification: Class II
Recalling firm: Alere San Diego, Inc.
Report date: Oct 7, 2026
Posted: Sep 25, 2026
Initiated: Aug 20, 2026
Center classification date: Sep 25, 2026
Product code: JHI
Device type: Visual, Pregnancy Hcg, Prescription Use
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
Quantity: 50,265,835
Code info: All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 5001/ 20612479202744/1155958203, 12/15; 92210/10815845020130/1156015803, 07/16; 23900530/00613647000571/1155810105, 2018-01-15; 23900531/00613647000533/1155810105, 2018-01-15; 5002/20612479202768/1155958305, 12/15; 92215/10815845020123/1156015903, 07/16; B-1077-23/20885380020268/1155904805, 9/2014; MPH22025HCG/10884389191880/1156093402, 04-01-2015
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.
Voluntary or mandated: Voluntary: Firm initiated
Related 510(k)s: K062361
Location: San Diego, CA, United States