{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "188497", "product_res_number": "Z-2351-2021", "event_date_initiated": "2021-07-28", "event_date_created": "2021-08-26", "recall_status": "Open, Classified", "res_event_number": "88362", "product_code": "LZG", "k_numbers": [ "K131029" ], "product_description": "Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001", "code_info": "Since this is a labeling correction, this recall is not lot specific and is\napplicable to all non-expired lots.", "firm_fei_number": "3011393376", "recalling_firm": "Roche Diabetes Care, Inc.", "address_1": "9115 Hague Rd", "city": "Indianapolis", "state": "IN", "postal_code": "46256-1025", "additional_info_contact": "Accu-Chek Customer Care\n1800-858-8072", "reason_for_recall": "Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decisions and adverse health consequences.", "root_cause_description": "Package design/selection", "action": "On July 28, 2021, the firm issued an Urgent Medical Device Correction to affected customers regarding the potential for open vials. Customers were warned that open vials may expose the test strips to humidity, which might damage the strips and result in inaccurate results (such as positively biased or falsely too high results). Inappropriate therapy decisions based on inaccurate results could lead to adverse health consequences.\n\nACTIONS REQUIRED BY USERS:\n\n1. Check vials of affected test strips before use. DO NOT use test strips if:\n\n- The vial is open or damaged before using the test strips for the first time\n- The cap is not fully closed\n- You see any damage to the cap or vial, or\n- Anything prevents the cap from closing properly\n\n2. DO NOT perform control testing if you open a sealed carton and ay of the vials inside meet the criteria listed above.\n\n3. Contact Accu-Chek Customer Care for product replacement if you open a sealed carton and any of the vials inside meet the criteria listed above by phone at 1-800-858-8072 or\non our website at Accu-Chek.com under Contact Us for email or chat. Please have the\naffected products available.\n\n4. Complete and return the business reply letter to the recalling firm.\n\n5. Dispose of the affected test strips and vial according to your local guidelines.\n\nContact Accu-Chek Customer Care if you have questions regarding the information in this\nUrgent Medical Device Correction(UMDC) by phone at 1-800-858-8072 or on our website at Accu-Chek.com under Contact Us for email or chat.", "product_quantity": "10,546,420 (US), 19,120,668 (OUS)", "distribution_pattern": "Worldwide distribution - US Nationwide distribution.", "openfda": { "k_number": [ "K103825", "K111353", "K100567", "K122483", "K023471", "K253534", "K083225", "K122953", "K180045", "K021439", "K143189", "K042887", "K022831", "K973044", "K093364", "K223372", "K210714", "K022317", "K082590", "K062323", "K050312", "K142619", "K900498", "K994186", "K160482", "K111210", "K013807", "K100504", "K111669", "K041318", "K073356", "K060876", "K051041", "K162080", "K182630", "K120206", "K133593", "K993184", "K013309", "K021725", "K042873", "K240158", "K020655", "K192659", "K884978", "K972107", "K063674", "K031541", "K960001", "K162296", "K993012", "K080639", "K901588", "K032164", "K963948", "K032257", "K030531", "K141758", "K040676", "K043000", "K131294", "K022394", "K991376", "K160252", "K063126", "K262153", "K905693", "K050760", "K160056", "K241622", "K990801", "K070844", "K071613", "K082595", "K211575", "K001604", "K050971", "K090245", "K031373", "K041317", "K071788", "K140439", "K042792", "K053177", "K031738" ], "registration_number": [ "3012421607", "1313700", "3013636348", "3002806818", "3007871880", "3042027705", "3020976354", "3008810357", "9617604", "3010047442", "9616814", "3009337401", "3001058982", "3008824097", "3009515470", "2029275", "1721676", "3014585508", "2246552", "3011393376", "3010291427", "3005340341", "3015218509", "3006194679", "3013756811", "3007710663", "3007981285", "2032227", "3010162782", "1220477", "3005627859", "3027453514", "3007939342", "3006479639", "3007007790", "3016540876", "9610126" ], "fei_number": [ "3012421607", "1313700", "3013636348", "3002806818", "3007871880", "3002806559", "3042027705", "3020976354", "3008810357", "3003166194", "3009337401", "3001058982", "3008824097", "3009515470", "1721676", "3014585508", "2246552", "3011393376", "3003024060", "3010291427", "3005340341", "3015218509", "3006194679", "3013756811", "3007981285", "1000306431", "3010162782", "3004173703", "1220477", "3005627859", "3027453514", "3007939342", "3002558692", "3006479639", "3007007790", "3016540876", "3010047442" ], "device_name": "Pump, Infusion, Insulin", "medical_specialty_description": "General Hospital", "regulation_number": "880.5725", "device_class": "2" } } ] }