{"recall":{"id":"fda-device-99531","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Diagnostica Stago, Inc. recalls STA Staclot Protein S","firm":"Diagnostica Stago, Inc.","date":"2026-07-29","reported":"2026-09-09","status":"Ongoing","classification":"Class II","products":[{"name":"STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test","code":"UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027","quantity":"5220 units","number":"Z-3047-2026","classification":"Class II"}],"reason":"A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US 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.","nationwide":true,"states":[],"units":"5220 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=99531","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"e129530e32fcf1b9","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=99531","record":[{"status":"Ongoing","city":"Parsippany","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99531","recalling_firm":"Diagnostica Stago, Inc.","address_1":"5 Century Dr","address_2":"N/A","postal_code":"07054-4607","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US 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.","recall_number":"Z-3047-2026","product_description":"STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074;   qualitative and quantitative factor deficiency test","product_quantity":"5220 units","reason_for_recall":"A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified","recall_initiation_date":"20260729","center_classification_date":"20260828","report_date":"20260909","code_info":"UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027","more_code_info":""}]}}