{"recall":{"id":"fda-device-99447","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Siemens Healthcare Diagnostics Products Ltd. recalls 2 products","firm":"Siemens Healthcare Diagnostics Products Ltd.","date":"2026-07-13","reported":"2026-08-26","status":"Ongoing","classification":"Class II","products":[{"name":"Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly","code":"Lot Code: D387/UDI: 00630414976891","quantity":"24 units","number":"Z-2965-2026","classification":"Class II"},{"name":"Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly","code":"Lot Code: D387/UDI(s):L2KSY2-00630414999791; L2KSY6 - 00630414999807","quantity":"478 units","number":"Z-2966-2026","classification":"Class II"}],"reason":"Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution in the states of FL, NJ, NY  and the countries of Austria, Azerbaijan, Belgium, Brazil, Chile, Colombia, Cura-ao, St.¿Eus Cyprus, France, Germany, Italy, Kazakhstan, Latvia, Lithuania, Netherlands, Romania, Russian¿Fed., Saudi¿Arabia, Slovakia, Slovenia, South¿Africa, Spain, U.A.E., Ukraine, United¿Kingdom, Uzbekistan.¿¿¿¿¿","nationwide":true,"states":[],"units":"24 units; 478 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=99447","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"bbdd927cbd669f7f","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=99447","record":[{"status":"Ongoing","city":"Caernarfon","state":"","country":"United Kingdom","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99447","recalling_firm":"Siemens Healthcare Diagnostics Products Ltd.","address_1":"Glyn Rhonwy","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states of FL, NJ, NY  and the countries of Austria, Azerbaijan, Belgium, Brazil, Chile, Colombia, Cura-ao, St.¿Eus Cyprus, France, Germany, Italy, Kazakhstan, Latvia, Lithuania, Netherlands, Romania, Russian¿Fed., Saudi¿Arabia, Slovakia, Slovenia, South¿Africa, Spain, U.A.E., Ukraine, United¿Kingdom, Uzbekistan.¿¿¿¿¿","recall_number":"Z-2965-2026","product_description":"Siemens Healthineers  Immulite 2000 Systems SYP Syphilis Screen  REF:L2KSY2(D)/10471981  IVD, RxOnly","product_quantity":"24 units","reason_for_recall":"Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.","recall_initiation_date":"20260713","center_classification_date":"20260814","report_date":"20260826","code_info":"Lot Code: D387/UDI: 00630414976891","more_code_info":""},{"status":"Ongoing","city":"Caernarfon","state":"","country":"United Kingdom","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99447","recalling_firm":"Siemens Healthcare Diagnostics Products Ltd.","address_1":"Glyn Rhonwy","address_2":"","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states of FL, NJ, NY  and the countries of Austria, Azerbaijan, Belgium, Brazil, Chile, Colombia, Cura-ao, St.¿Eus Cyprus, France, Germany, Italy, Kazakhstan, Latvia, Lithuania, Netherlands, Romania, Russian¿Fed., Saudi¿Arabia, Slovakia, Slovenia, South¿Africa, Spain, U.A.E., Ukraine, United¿Kingdom, Uzbekistan.¿¿¿¿¿","recall_number":"Z-2966-2026","product_description":"Siemens Healthineers  Immulite 2000 Systems SYP Syphilis Screen  REF(s):L2kSY2/10489085; L2KSY6/10488319  IVD, RxOnly","product_quantity":"478 units","reason_for_recall":"Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive.","recall_initiation_date":"20260713","center_classification_date":"20260814","report_date":"20260826","code_info":"Lot Code: D387/UDI(s):L2KSY2-00630414999791; L2KSY6 - 00630414999807","more_code_info":""}]}}