{"recall":{"id":"fda-device-99537","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Healthmark Industries Co., Inc. recalls 2 products","firm":"Healthmark Industries Co., Inc.","date":"2026-07-29","reported":"2026-09-02","status":"Ongoing","classification":"Class II","products":[{"name":"healthmark ProChek-II, Model Number PT-313, PT-201-12","code":"PT-313 - Serial/Lot Numbers: 3000535312, 3000535333, 3000536416, 3000536423, 3000537810, 3000537822, 3000542453, 3000545623, 3000550099, 3000550512, 313069, 313072, 313073, 313074, 313075, 313076, 313077, 313078, 313079, 313080, 313081, 313082, 313083, 313084, 313085, 313086, 313087, 313088, 313089, 313090, 313091, 313092, 313093, 313094, 313095, 313096, 313097, 313098, 313099, 313100, 313101, 313102, 313106, 313107; H-PT-201-12 - Serial/Lot Numbers: 7P0110, 7P0111, 7P0113, 7P0122.","quantity":"5090 units","number":"Z-3031-2026","classification":"Class II"},{"name":"healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001","code":"Serial/Lot Numbers: 200035, 200036, 200037, 200038, 200039, 200040, 30028.","quantity":"53 units","number":"Z-3032-2026","classification":"Class II"}],"reason":"Test manufactured with an expired ingredient which may present as either a false negative or positive.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.","nationwide":true,"states":[],"units":"5090 units; 53 units","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=99537","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"b60915437741139b","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=99537","record":[{"status":"Ongoing","city":"Fraser","state":"MI","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99537","recalling_firm":"Healthmark Industries Co., Inc.","address_1":"18600 Malyn Blvd","address_2":"N/A","postal_code":"48026-3496","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.","recall_number":"Z-3031-2026","product_description":"healthmark ProChek-II, Model Number PT-313, PT-201-12","product_quantity":"5090 units","reason_for_recall":"Test manufactured with an expired ingredient which may present as either a false negative or positive.","recall_initiation_date":"20260729","center_classification_date":"20260826","report_date":"20260902","code_info":"PT-313 - Serial/Lot Numbers:  3000535312, 3000535333, 3000536416, 3000536423, 3000537810, 3000537822, 3000542453, 3000545623, 3000550099, 3000550512, 313069, 313072, 313073, 313074, 313075, 313076, 313077, 313078, 313079, 313080, 313081, 313082, 313083, 313084, 313085, 313086, 313087, 313088, 313089, 313090, 313091, 313092, 313093, 313094, 313095, 313096, 313097, 313098, 313099, 313100, 313101, 313102, 313106, 313107;    H-PT-201-12 - Serial/Lot Numbers:  7P0110, 7P0111, 7P0113, 7P0122."},{"status":"Ongoing","city":"Fraser","state":"MI","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99537","recalling_firm":"Healthmark Industries Co., Inc.","address_1":"18600 Malyn Blvd","address_2":"N/A","postal_code":"48026-3496","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"Worldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea.","recall_number":"Z-3032-2026","product_description":"healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001","product_quantity":"53 units","reason_for_recall":"Test manufactured with an expired ingredient which may present as either a false negative or positive.","recall_initiation_date":"20260729","center_classification_date":"20260826","report_date":"20260902","code_info":"Serial/Lot Numbers:  200035, 200036, 200037, 200038, 200039, 200040, 30028."}]}}