{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "104528", "product_res_number": "Z-0311-2012", "event_date_initiated": "2011-10-18", "event_date_posted": "2011-11-30", "recall_status": "Terminated", "event_date_terminated": "2013-02-21", "res_event_number": "60146", "product_code": "JJE", "k_numbers": [ "K071211" ], "product_description": "Roche Cobas c 111 Analyzer\nThe Roche Cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.", "code_info": "Serial Numbers 50865, 50626, 50798, 50731, 50654, 50541, 51023, 50946, 50989, 50634, 50506, 50251, 50887, 50948, 50453, 50688, 51111, 50997, 51122, 50244, 50790, 50475, 50597, 50740, 50656, 50793, 51086, 50999, 51146, 50635, 50744, 50586, 50632, 50846, 1167, 50693, 50787, 50670, 50672, 51128, 50941, 50562, 50788, 50547, 51003, 50624, 50677, 50678, 50814, 51015, 50687, 50680, 50894, 50560, 51004, 50247, 50538, 51118, 50926, 50847, 50841, 51127, 50741, 50764, 50633, 51106, 51116, 50201, 51124, 50612, 51088, 50576, 51016, 50689, 50681, 50424, 51126, 50959, 50878, 50784, 50661, 50761, 50452, 50450, 50290, 50947, 51327, 50630, 50985, 50763, 50319, 50984, 50250, 50549, 50925, 50844, 50660, 50845, 50683, 50735, 51056, 50463, 50775, 50840, 50734, 50655, 50843, 50758, 50852, 50539, 50651, 50653, 50657, 50964, 50563, 50742, 50738, 50727, 50934, 50561, 50803, 51000, 51107, 50686, 50815, 50649, 50470, 50759, 50644, 51053, 50739, 50595, 51087, 50575, and 50679.", "firm_fei_number": "1823260", "recalling_firm": "Roche Diagnostics Operations, Inc.", "address_1": "9115 Hague Road", "city": "Indianapolis", "state": "IN", "postal_code": "46256-1025", "additional_info_contact": "317-576-2000 Ext. 249", "reason_for_recall": "Internal investigations have revealed a potential printer malfunction on the Cobas c 111 analyzer, where one or more numbers or characters can be missing on the hard copy result printout, or the printer may skip leaving blanks which may result in an incorrect print layout. The missing number of characters can be in any position, therefore it could be in the middle of a result, (e.g. 48.53 mmol in", "root_cause_description": "Software design", "action": "Roche Diagnostics Operations, Inc sent a Urgent Medical Device Correction dated October 18, 2011, via UPS Ground (receipt required) to all affected customers and one distribution center, with instructions to disable the Auto Print Result feature until new software is available. All printed results will need to be confirmed against the results indicated on the display screen. \n\nQuestions are to be directed to Roche Diagnostics Technical Support at 1-800 428-2336,", "product_quantity": "135", "distribution_pattern": "Worldwide Distribution - USA including West Virginia and Texas.", "openfda": { "k_number": [ "K833448", "K930489", "K840868", "K760642", "K882914", "K890184", "K853699", "K950958", "K873617", "K780388", "K912024", "K840129", "K971761", "K813102", "K040958", "K863840", "K851638", "K942443", "K904219", "K963539", "K872104", "K882081", "K832584", "K843283", "K940289", "K884378", "K885289", "K772344", "K860080", "K802835", "K832115", "K853003", "K872813", "K946090", "K912844", "K832648", "K945135", "K792361", "K073370", "K860021", "K820888", "K933703", "K822465", "K885226", "K940810", "K823386", "K842773", "K853391", "K852133", "K112999", "K962235", "K844114", "K780083", "K841076", "K771345", "K843059", "K811919", "K831649", "K864849", "K920402", 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