{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "177239", "product_res_number": "Z-0749-2020", "event_date_initiated": "2019-09-30", "event_date_posted": "2019-12-30", "recall_status": "Terminated", "event_date_terminated": "2020-07-29", "res_event_number": "84119", "product_code": "NBW", "product_description": "Blood Glucose Monitoring System, Model Number 07400942001\nACCU-CHEK GUIDE METER ONLY MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.", "code_info": "Model Number : 07400942001 Device Identifier: 00365702702066 All serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number).", "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\n800-858-8072", "reason_for_recall": "Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.", "root_cause_description": "Device Design", "action": "On October 23, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail for the Accu-Chek Guide blood glucose meters with a serial number below 92311000001. The serial\nnumber can be found on the back of the meter, where indicated by the red rectangle\nin the photo below. It instructs them to:\n1) Always have a spare set of batteries. The meter requires two (2) size CR2032 batteries.\n2) Be aware that battery life may vary due to factors such as temperature and battery manufacturer.\n3) Have a back-up testing method available.\n4) If you have questions regarding this notification or you need further support, please contact our Accu-Chek Customer Care team through our website (accuchek.com), email address (accu-chek.care@roche.com), or call (1-800-858-8072).\n5) If there is a Business Reply Card enclosed with this mailing, please complete and return it as\ninstructed on the Business Reply Card.\n6) Keep a copy of this notification for your records.\n\nIf you are currently experiencing a power issue with your Accu-Chek Guide meter, follow the\ninstructions below.\nIf the meter is powered on and displaying an E-9 error or low battery icon:\na. Move the meter to a more moderate environment, such as ambient room temperature, to ensure\noptimal battery performance.\nb. Turn the meter off, then turn the meter back on.\nc. If the problem persists, perform a meter reset by doing the following:\ni) Remove the batteries.\nii) Press and hold the Power/Set/OK button for at least 2 seconds.\niii) Reinsert the batteries.\nd. If the problem still occurs after performing a meter reset, then replace the batteries with new\nones according to the instructions in the user manual. Use high quality batteries in the meter,\nsuch as Panasonic. The meter requires two (2) size CR2032 batteries.\ne. If replacing the batteries does not correct the situation, please contact our Accu-Chek Customer\nCare team through our website (accu-chek.com), email address (accu-chek", "product_quantity": "21,094", "distribution_pattern": "US Nationwide distribution and countries of AR, AT, AU, BE, BR, CA, CH, CL, DE, DK, EC, ES, FI, FR, GB, GR, HK, HR, ID, IN, IT, JP, KR, LB, LT, LU, MM, MY, NL, NO, PH, PK, PT, SE, SG, TH, TW, ZA.", "openfda": { "k_number": [ "K130138", "K172723", "K222234", "K123935", "K040848", "K081715", "K090057", "K170064", "K120558", "K090188", "K133522", "K062770", "K223722", "K153286", "K091898", "K181316", "K123089", "K170267", "K052208", "K080538", "K043340", "K021513", "K120568", "K090405", "K030703", "K150214", "K160742", "K160365", "K201037", "K121133", "K061118", "K081703", "K011738", "K133741", "K092902", "K072543", "K123136", "K082201", "K102678", "K070472", "K112738", "K123559", "K073118", "K052108", "K042005", "K150274", "K230625", "K123517", "K112275", 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