{"recall":{"id":"fda-device-99518","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Greiner Bio-One North America, Inc. recalls Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Descript","firm":"Greiner Bio-One North America, Inc.","date":"2026-07-29","reported":"2026-10-28","status":"Ongoing","classification":"Class II","products":[{"name":"Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel Separator (13 x 75 mm, 3.5ml)","code":"Lot Code: Item Number: 454008P Lot Number: B26043FM UDI: Rack: 29120017579032, Case: 39120017579039 Expiration Date: 2027-07-12","quantity":"860450","number":"Z-0200-2027","classification":"Class II"}],"reason":"Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results which have the potential to cause hyperkalemia.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"U.S. Nationwide distribution in the states of CO, FL, IL, MO, NE, NY, OH, PA, and VA.","nationwide":true,"states":[],"units":"860450","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=99518","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"32a88ccb1bd9705e","firstSeen":"2026-11-02T22:17:07.772Z","updatedAt":"2026-11-02T22:17:07.772Z","history":[]},"official":{"fetchedAt":"2026-11-02T22:17:07.772Z","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=99518","record":[{"status":"Ongoing","city":"Monroe","state":"NC","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99518","recalling_firm":"Greiner Bio-One North America, Inc.","address_1":"4238 Capital Dr","address_2":"","postal_code":"28110-7681","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"U.S. Nationwide distribution in the states of CO, FL, IL, MO, NE, NY, OH, PA, and VA.","recall_number":"Z-0200-2027","product_description":"Brand Name: VACUETTE  Product Name: LH Lithium Heparin Separator  Model/Catalog Number: 454008P  Product Description: Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel Separator (13 x 75 mm, 3.5ml)","product_quantity":"860450","reason_for_recall":"Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results which have the potential to cause hyperkalemia.","recall_initiation_date":"20260729","center_classification_date":"20261021","report_date":"20261028","code_info":"Lot Code: Item Number: 454008P Lot Number: B26043FM UDI: Rack: 29120017579032, Case: 39120017579039 Expiration Date:  2027-07-12","more_code_info":""}]}}