{"recall":{"id":"fda-device-99409","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Alere San Diego, Inc. recalls 4 products","firm":"Alere San Diego, Inc.","date":"2026-08-20","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"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;","code":"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","quantity":"50,265,835","number":"Z-3271-2026","classification":"Class II"},{"name":"Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025; Henry Schein One Step+ hCG Combo test in Serum or Urine, Model/ Part: FHC-202/9004075; Alere hCG Combo Cassette (25mIU/mL) in Urine (CLIA Waived) or Serum, Model/ Part: FHC-202/92225; Pro Advantage By NDC Urine/Serum Pregnancy Cassette Device, Model/ Part: FHC-202/P080021","code":"All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 23900529/00613647000540/1155810906, 2018-01-15; 23900528/00613647000564/1155810906, 2018-01-15; 43025/15099590776886/May 2015; 9004075/10304040024123/1155875804, 2014-06-09; 92225/10815845020116/1156015603, 07/16; P080021/M220P0800213/40001856, 2023-03-30","quantity":"5,331,585","number":"Z-3272-2026","classification":"Class II"},{"name":"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;","code":"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","quantity":"13,256,075","number":"Z-3273-2026","classification":"Class II"},{"name":"Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074, FHC-102/9004073; Alere hCG Cassette (25mIU/mL) in Urine, Model/ Part: FHC-102/92217; Cardinal Health hCG Cassette Rapid test CLIA Waived, Model/ Part: FHC-102/B1077-22; Medline HCG Pregnancy Test Cassette, Model/ Part: FHC-102/MPH12025HCG; Pro Advantage By NDC Urine Pregnancy Cassette Device, Model/ Part: FHC-102/P080063;","code":"All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 23900526/00613647000526/1155811105, 2018-01-15; 9004074/10304040024116/1155875704, 2014-06-09; 9004073/10304040024109/1155875704, 2014-06-09; 92217/10815845020109/1156015703, 07/16; B1077-22/20885380020251/1155904704, 9/2014; MPH12025HCG/10888277191877/1156093302, 2015-03-20; P080063/M220P0800633/40001853, 2023-03-30","quantity":"18,139,960","number":"Z-3274-2026","classification":"Class II"}],"reason":"hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"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.","nationwide":true,"states":[],"units":"50,265,835; 5,331,585; 13,256,075; 18,139,960","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99409","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"36cbfe0f2ef8fa91","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99409","record":[{"status":"Ongoing","city":"San Diego","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99409","recalling_firm":"Alere San Diego, Inc.","address_1":"9942 mesa rim rd","address_2":"","postal_code":"92121-2997","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","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.","recall_number":"Z-3271-2026","product_description":"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;","product_quantity":"50,265,835","reason_for_recall":"hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.","recall_initiation_date":"20260820","center_classification_date":"20260925","report_date":"20261007","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","more_code_info":""},{"status":"Ongoing","city":"San Diego","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99409","recalling_firm":"Alere San Diego, Inc.","address_1":"9942 mesa rim rd","address_2":"","postal_code":"92121-2997","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","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.","recall_number":"Z-3272-2026","product_description":"Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528;    Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025;    Henry Schein One Step+ hCG Combo test in Serum or Urine, Model/ Part: FHC-202/9004075;    Alere hCG Combo Cassette (25mIU/mL) in Urine (CLIA Waived) or Serum, Model/ Part: FHC-202/92225;     Pro Advantage By NDC Urine/Serum Pregnancy Cassette Device, Model/ Part: FHC-202/P080021","product_quantity":"5,331,585","reason_for_recall":"hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.","recall_initiation_date":"20260820","center_classification_date":"20260925","report_date":"20261007","code_info":"All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 23900529/00613647000540/1155810906, 2018-01-15; 23900528/00613647000564/1155810906, 2018-01-15; 43025/15099590776886/May 2015; 9004075/10304040024123/1155875804, 2014-06-09; 92225/10815845020116/1156015603, 07/16;  P080021/M220P0800213/40001856, 2023-03-30","more_code_info":""},{"status":"Ongoing","city":"San Diego","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99409","recalling_firm":"Alere San Diego, Inc.","address_1":"9942 mesa rim rd","address_2":"","postal_code":"92121-2997","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","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.","recall_number":"Z-3273-2026","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;","product_quantity":"13,256,075","reason_for_recall":"hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.","recall_initiation_date":"20260820","center_classification_date":"20260925","report_date":"20261007","code_info":"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","more_code_info":""},{"status":"Ongoing","city":"San Diego","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99409","recalling_firm":"Alere San Diego, Inc.","address_1":"9942 mesa rim rd","address_2":"","postal_code":"92121-2997","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","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.","recall_number":"Z-3274-2026","product_description":"Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526;  Henry Schein, Inc. One Step + Urine Cassette Test, Model/ Part: FHC-102/9004074, FHC-102/9004073;  Alere hCG Cassette (25mIU/mL) in Urine, Model/ Part: FHC-102/92217;  Cardinal Health hCG Cassette Rapid test CLIA Waived, Model/ Part: FHC-102/B1077-22;  Medline HCG Pregnancy Test Cassette, Model/ Part: FHC-102/MPH12025HCG;  Pro Advantage By NDC Urine Pregnancy Cassette Device, Model/ Part: FHC-102/P080063;","product_quantity":"18,139,960","reason_for_recall":"hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.","recall_initiation_date":"20260820","center_classification_date":"20260925","report_date":"20261007","code_info":"All lots within the expiration date. Parts/UDI-DI/Labeling Versions Through: 23900526/00613647000526/1155811105, 2018-01-15; 9004074/10304040024116/1155875704, 2014-06-09; 9004073/10304040024109/1155875704, 2014-06-09; 92217/10815845020109/1156015703, 07/16; B1077-22/20885380020251/1155904704, 9/2014; MPH12025HCG/10888277191877/1156093302, 2015-03-20; P080063/M220P0800633/40001853, 2023-03-30","more_code_info":""}]}}