{ "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": "2026-04-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Indianapolis", "state": "IN", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "87102", "recalling_firm": "Roche Diagnostics Operations, Inc.", "address_1": "9115 Hague Rd", "address_2": "N/A", "postal_code": "46256-1025", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "US Nationwide distribution.", "recall_number": "Z-1098-2021", "product_description": "9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in the whole blood, serum or plasma, urine, dialysate solutions, or QC materials. catalog number 03157334001 . in vitro diagnostic use.", "product_quantity": "1,214 units", "reason_for_recall": "May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of results and incorrect medical decision. If the unit for iCa++ is set to mg/dL (configured as Service Code MGL) and a measured iCa++ value is lower than the normal range, an upward arrow is shown on the display instead of a downward arrow. The display is set per default to mmol/L; therefore, the arrow indicating an alarm reflects normal ranges of iCa++ in mmol/L. If mg/dL is chosen, the arrow warnings on screen still reflect the ranges from mmol/L, rather than mg/dL. The numeric result is displayed correctly.", "recall_initiation_date": "20210106", "center_classification_date": "20210208", "termination_date": "20240228", "report_date": "20210217", "code_info": "All Serial Numbers: U18.5093 U18.2418 U18.1099 U18.4188 U18.2819 13002 U18.3698 U18.4498 U18.3629 U18.3056 U18.3058 U18.2954 U18.4423 U18.4584 17769 U18.3657 U18.2026 U18.2245 13982 U18.2839 7148 7151 15061 27989 7143 U18.3533 U18.3590 U18.6311 U18.5772 5925 U18.5230 6265 U18.4798 U18.1900 17760 U18.3447 7157 U18.5809 U18.4696 U18.4698 19313 U18.3216 U18.3259 U18.3599 12853 U18.2144 U18.3519 U18.6131 U18.3648 U18.2430 U18.1138 U18.3137 U18.2334 U18.2972 U18.1554 U18.3537 U18.4440 U18.1160 U18.4014 U18.3324 U18.2006 24119 U18.3717 U18.1175 U18.1555 U18.4181 U18.2070 U18.6807 U18.2725 U18.1173 15217 U18.2172 U18.2727 U18.4357 U18.2441 15408 16650 22334 22336 U18.2277 U18.3052 U18.2110 U18.4254 U18.5501 U18.4755 U18.4230 U18.4365 U18.3638 U18.3089 15071 U18.3215 6836 6841 18016 U18.3789 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U18.5229 12365 U18.3128 U18.3364 U18.4019 U18.2735 12785 13038 13107 13108 13112 13114 13115 13117 U18.2292 U18.2294 U18.3348 U18.2168 U18.3612 15851 U18.1935 14310 U18.2427 U18.3059 U18.5102 U18.2749 13975 U18.4521 13028 U18.2488 6640 15544 U18.4943 13141 U18.3118 U18.2269 13778 13788 13638 U18.1116 U18.3931 U18.7168 U18.3915 12925 U18.1338 U18.1389 U18.6564 U18.2252 U19.6985 U18.1623 13024 U19.1477 U18.1228 U18.6130 U18.1111 U18.2519 U18.1127 U18.2741 U18.2091 13828 U18.5388 7149 U18.5070 U18.5382 U18.2574 U18.1505 U18.4497 U18.3885 U18.1434 U18.1931 U18.1227 6314 U18.3016 U18.2573 U18.3754 U18.1126 U18.1985 6634 U18.3044 U18.2468 U18.3616 U18.3534 U18.3161 14281 U18.2734 U18.2480 U18.4602 U18.4437 U18.2708 U18.4264 U18.6840 15067 U18.1932 U18.4758 U18.3149 U18.3520 12354 U18.4522 U18.4442 U18.3919 19064 U18.1326 U18.2031 U18.12291 U18.1390 U18.1405 U18.2594 U18.7165 U18.3609 U18.3621 18667 U18.4899 U18.3535 U18.4212 U18.3212 U18.2739 U18.2076 U18.2799 U18.5156 17035 22173 U18.2511 U18.3160 14294 6986 15784 7114 U18.1793 U18.5094 U18.1152 U18.1680 15412 26236 U18.2000 23658 U18.4038 U18.3996 U18.7175 14288 U18.2592 U18.2905 U18.1868 6633 U18.2941 U18.5651 U18.4235 16215 U18.1775 U18.6801 U18.2823 U18.3526 U18.3528 U18.3708 U18.1198 U18.5084 6257 U18.3393 14702 U18.4012 U18.1303 U18.1064 U18.3092 7159 U18.1725 U18.1042 U18.2913 U18.3346 U18.2011 12901 U18.4185 U18.3226 U18.3417 U18.4204 U18.2683 12367 U18.5001 U18.2945 U18.2878 U18.2270 6806 U18.5824 U18.4386 U18.3300 U18.2556 U18.4434 U18.3296 U18.2979 U18.2254 5823 U18.7107 U18.5891 U18.4013 U18.2251 15233 16359 U18.2908 U18.2919 U18.6832 14728 U18.1757 U18.3228 U18.4701 12374 U18.3779 U18.6632 U18.2204 19583 U18.7166 19449 13810 U18.2501 12366 U18.3705 12416 U18.2352 U18.2213 U18.4894 A18.12661 U18.6127 U18.1933 U18.5088 U18.2236 14980 U18.6396 U18.2745 U18.1981 U18.1129 U18.3964 28016 U18.4704 U18.4262 14280 U18.1869 13583 U18.3241 A18.12266 A18.12280 U18.12216 24503 U18.3798 U18.2291 U18.4571 U18.4797 U18.1106 U18.5217 14474 14585 22852 U18.2442 7142 U18.2820 U18.3006 U18.2043 U18.3229 U18.1847 13019 U18.5228 U18.4799 U18.2137 U18.3227 U18.3433 U18.3238 U18.2469 15707 24413 U18.4088 U18.3795 21678 12369 U18.4196 U18.1185 14287 14469 19572 U18.2658 U18.3132 13101 U18.3046 6138 6132 6133 U18.2943 U18.2947 U18.3062 U18.6133 12680 12683 12684 14548 U18.2470 U18.2702 U18.2455 19564 19567 U18.4884 15416 U18.6316 23591 U18.2569 U18.3255 13829 U18.3357 22176 22854 U18.12282 6637 U18.3723 U18.1766 U18.6645 16358 22177 U18.12267 U18.4892 19603 U18.12268 U18.1633 U18.2714 U18.4362 U18.3801 U18.2558 U18.4183 U18.5806 U18.3065 U18.2875 U18.3068 13486 U18.4359 17576 U18.4366 U18.3777 U18.4016 U18.2012 U18.2851 U18.2983 U18.7167 U18.3809 U18.2025 18527 U18.3069 U18.3140 5829 6311 13763 U18.2004 U18.6808 U18.4576 U18.7152 U18.7153 24122 U18.3386 U18.2566 U18.7172 U18.2053 18533 U18.2326 U18.3642 18180 12876 15551 U18.5341 U18.2858 U18.3916 6282 U18.6638 U18.3753 U18.4002 U18.3355 18144 U18.1811 U18.4532 6394 U18.6635 U18.3793 U18.2701 U18.2796 U18.2896 U18.2982 U18.2980 U18.2981 U18.2976 6641 13976 U18.2290 U18.3695 U18.6137 18615 U18.4250 U18.2790 U18.2232 U18.4499 U18.1416 U18.2746 U18.1162 U18.7171 13614 U18.2244 U18.2950 U18.3681 28809 28810 28796 29242 24895 28464 28805 24502 5827 6136 29210 5825 12564 12571 12584 12603 12605 13964 13967 13972 22845 23713 24024 24025 24495 24491 24614 25319 25317 5819 5822 5931 5923 6258 6396 6284 6643 U18.1110 6646 6808 7146 7168 7167 7106 U18.12263 U18.12374 12547 12495 12604 12728 U18.5805 12813 13016 13157 13772 14317 14374 14590 14546 15060 15349 17467 18464 18478 18576 18591 18593 18594 18560 18562 18564 18611 18613 18614 19227 19261 19402 19411 19573 19579 19560 21924 23206 24406 24117 25516 26246 26130 26465 27500 27604 28153 28304 29055 15415 26097 26192 26367 26366 26739 27143 27167 27187 27188 27569 27570 27529 27521 27755 28135 27930 28154 28233 15419 18022 28155" } ] }