{"url_path":"/fda/device/recalls/Z-3047-2026","section_key":"summary","section_title":"DEVICE Recall: Diagnostica Stago, Inc. — STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074;   qualitative and quantitative factor deficiency test","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-3047-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Diagnostica Stago, Inc."},"word_count":97,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3047-2026\n\n**Recalling firm:** Diagnostica Stago, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-29\n**Report date:** 2026-09-09\n\n## Product\nSTA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074;   qualitative and quantitative factor deficiency test\n\n## Reason\nA positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified\n\n## Affected lots\nUDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027\n\n## Distribution\nUS Nationwide distribution in the states and territory of NJ, NY, NJ, VA, PA, FL, AL, GA, TN, OH, IL, MO, NE, TX, CO, UT, CA, PR."}