{"recall":{"id":"fda-device-99776","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Test Kit","firm":"Magellan Diagnostics, Inc.","date":"2026-09-04","reported":"2026-10-21","status":"Ongoing","classification":"Class III","products":[{"name":"LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.","code":"Model/Catalog Number: 70-6762. UD-DI: 00850355006000. Lot Number. 2530M-01.","quantity":"321 units","number":"Z-0162-2027","classification":"Class III"}],"reason":"In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an error message and prevent the operator from running the test. Resulting in delayed results.","hazard":"FDA Class III: not likely to cause adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY.","nationwide":true,"states":[],"units":"321 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=99776","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"fde88fd95754bb60","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=99776","record":[{"status":"Ongoing","city":"North Billerica","state":"MA","country":"United States","classification":"Class III","openfda":{},"product_type":"Devices","event_id":"99776","recalling_firm":"Magellan Diagnostics, Inc.","address_1":"101 Billerica Ave Bldg 4","address_2":"","postal_code":"01862-1271","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY.","recall_number":"Z-0162-2027","product_description":"LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.","product_quantity":"321 units","reason_for_recall":"In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026.  If used the system will display an error message and prevent the operator from running the test. Resulting in delayed results.","recall_initiation_date":"20260904","center_classification_date":"20261015","report_date":"20261021","code_info":"Model/Catalog Number: 70-6762. UD-DI: 00850355006000. Lot Number. 2530M-01.","more_code_info":""}]}}