{"url_path":"/fda/device/recalls/Z-3031-2026","section_key":"summary","section_title":"DEVICE Recall: Healthmark Industries Co., Inc. — healthmark ProChek-II, Model Number PT-313, PT-201-12","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-07-29","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3031-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Healthmark Industries Co., Inc."},"word_count":127,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3031-2026\n\n**Recalling firm:** Healthmark Industries Co., Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-29\n**Report date:** 2026-09-02\n\n## Product\nhealthmark ProChek-II, Model Number PT-313, PT-201-12\n\n## Reason\nTest manufactured with an expired ingredient which may present as either a false negative or positive.\n\n## Affected lots\nPT-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.\n\n## Distribution\nWorldwide distribution - US Nationwide and the countries of Canada, France, Hong Kong, South Korea."}