{"recall":{"id":"fda-device-99799","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"DRG International, Inc. recalls Sperm Ab ELISA","firm":"DRG International, Inc.","date":"2026-07-02","reported":"2026-10-14","status":"Ongoing","classification":"Class II","products":[{"name":"Sperm Ab ELISA; Model/Catalog Number: EIA-1826; Product Description: Sperm Ab ELISA (96 well plate test);","code":"Model/Catalog Number: EIA-1826; UDI: 04048474018264; Lot# 320K046;","quantity":"211","number":"Z-0082-2027","classification":"Class II"}],"reason":"Potential for false negative patient results.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution in the state of NJ and the countries of Azerbaijan, Belgium, Czech Republic, Germany, Hungary, India, Italy, Kuwait, Russia, Spain, Ukraine.","nationwide":true,"states":[],"units":"211","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=99799","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"92e379fc1ad8e15d","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=99799","record":[{"status":"Ongoing","city":"Springfield","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99799","recalling_firm":"DRG International, Inc.","address_1":"841 Mountain Ave","address_2":"N/A","postal_code":"07081-3437","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the state of NJ and the countries of Azerbaijan, Belgium, Czech Republic, Germany, Hungary, India, Italy, Kuwait, Russia, Spain, Ukraine.","recall_number":"Z-0082-2027","product_description":"Sperm Ab ELISA;  Model/Catalog Number: EIA-1826;  Product Description: Sperm Ab ELISA (96 well plate test);","product_quantity":"211","reason_for_recall":"Potential for false negative patient results.","recall_initiation_date":"20260702","center_classification_date":"20261002","report_date":"20261014","code_info":"Model/Catalog Number: EIA-1826; UDI: 04048474018264; Lot# 320K046;"}]}}