{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-28", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "221510", "product_res_number": "Z-3271-2026", "event_date_initiated": "2026-08-20", "event_date_posted": "2026-09-25", "recall_status": "Open, Classified", "res_event_number": "99409", "product_code": "JHI", "k_numbers": [ "K062361" ], "product_description": "McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001;\r\nAlere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210;\r\nFisher Scientific Sure-Vue Serum/UrinehCG-STAT, Model/ Part: FHC-A202/23900531,\r\nFHC-A202/23900530;\r\nMcKesson CONSULT Diagnostics hCG Urine Cassette, Model/ Part: FHC-A202/5002;\r\nAlere hCG Combo Cassette (20/10 mIU/mL) for Urine or Serum, Model/ Part: FHC-A202/92215;\r\nCardinal Health hCG Combo Rapid Test Serum or Urine, Model/ Part: FHC-A202/B-1077-23;\r\nMedline hCG Combo Pregnancy Test Cassette, Model/ Part: FHC-A202/MPH22025HCG;", "code_info": "All lots within the expiration date.\nParts/UDI-DI/Labeling Versions Through:\n5001/ 20612479202744/1155958203, 12/15;\n92210/10815845020130/1156015803, 07/16;\n23900530/00613647000571/1155810105, 2018-01-15;\n23900531/00613647000533/1155810105, 2018-01-15;\n5002/20612479202768/1155958305, 12/15;\n92215/10815845020123/1156015903, 07/16;\nB-1077-23/20885380020268/1155904805, 9/2014;\nMPH22025HCG/10884389191880/1156093402, 04-01-2015", "firm_fei_number": "1000125596", "recalling_firm": "Alere San Diego, Inc.", "address_1": "9942 mesa rim rd", "city": "San Diego", "state": "CA", "postal_code": "92121-2997", "additional_info_contact": "Monika Burrell\n858-805-2506 Ext. 3015", "reason_for_recall": "hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.", "root_cause_description": "Device Design", "action": "On 8/20/2026, correction notices started being emailed to customers and distributors informing them to take the following actions:\n\n1) 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.\n2) 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.\n3) Retain this letter for your records.\n4) Acknowledge receipt of this letter. Your organization s reply provides us with the necessary documentation to monitor the effectiveness of the field action notification.\n\nIf you have questions regarding this information, U.S. Customers please contact the firm's Technical Services at 877-308-8289", "product_quantity": "50,265,835", "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.", "openfda": { "k_number": [ "K894175", "K123844", "K830526", "K992695", "K882155", "K822515", "K801244", "K930014", "K822343", "K844082", "K974851", "K880070", "K820942", "K831264", "K850727", "K945969", "K926204", "K955266", "K871308", "K863199", "K051841", "K853006", "K840328", 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"medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1155", "device_class": "2" } } ] }