Class 2 Device Recall Roche 9180 Electrolyte Analyzer

• Date Initiated by Firm: January 06, 2021
• Date Posted: February 08, 2021
• Recall Status: Terminated on February 28, 2024
• Recall Number: Z-1098-2021
• Recall Event ID: 87102
• 510(K)Number: K961458
• Product Classification: Electrode, ion specific, calcium - Product Code JFP
• Product: 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.
• Code Information: 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 U18.4243 U18.5644 U18.6395 U18.3390 U18.6644 U18.2679 U18.3096 U18.3064 U18.3635 12879 U18.3745 19537 17151 U18.4431 U18.3279 U18.4330 27753 19581 U18.2350 U18.4265 U18.1498 13667 U18.2828 U18.3384 25517 13983 13762 14981 15409 17202 14732 26969 U18.2946 U18.2789 U18.1461 U18.2593 U18.3397 U18.1772 U18.1777 U18.7156 U18.5830 U18.3613 12405 U18.4385 U18.3414 U18.1678 U18.5922 6981 U18.2814 U18.4750 U18.3604 19562 24115 U18.2797 U18.1341 26424 26738 U18.1563 U18.4017 U18.2850 U18.3051 U18.3675 U18.2865 U18.5261 U18.3449 U18.1504 U18.2420 U18.4208 6263 U18.2816 U18.4260 U18.2249 17422 U18.4198 U18.6258 U18.5085 15804 U18.7177 U18.4315 U18.1334 U18.3794 14544 U18.3799 U18.2238 12824 6642 19626 25519 U18.2504 U18.2276 U18.1072 23712 A18.12710 U18.2849 24629 U18.2514 U18.3536 U18.2020 U18.4867 U18.2438 U18.2808 U18.3018 16509 U18.1323 12924 14567 21847 U18.2422 U18.1130 U18.1177 7145 U18.3522 U18.3133 U18.3487 U18.4223 A18.12282 7154 12812 U18.1345 14309 U18.1109 U18.6309 U18.2248 U18.1193 U18.3715 U18.3298 U18.2013 U18.2341 U18.4215 U18.1783 U18.3193 U18.3670 U18.2825 12375 U18.1740 U18.4382 U18.6393 U18.3545 6838 U18.4199 U18.2551 U18.2553 U18.4506 U18.2452 U18.2591 15418 U18.4592 19106 U18.1108 U18.3884 U18.2071 U18.2068 U18.3045 U18.3039 U18.3434 U18.3243 13668 U18.4593 U18.4608 U18.2015 U18.3737 U18.6399 U18.2056 6308 U18.1433 U18.7169 24609 U18.4371 14589 U18.1789 U18.3527 U18.2859 U18.2478 U18.2021 U18.4621 U18.4620 U18.1136 U18.3600 14427 16087 16219 U18.3257 U18.3643 12792 U18.2650 U18.3625 U18.2072 U18.3990 U18.2018 U18.4997 U18.3724 U18.1174 U18.5227 U18.1172 U18.3302 U18.3190 U18.3134 17596 U18.2656 U18.2657 U18.2899 U18.3454 U18.3655 U18.2486 19632 U18.3586 U18.1851 U18.3598 14425 U18.4252 U18.2010 U18.3091 U18.2539 U18.2684 U18.3755 U18.3146 16360 U18.1905 U18.3750 U18.2726 U18.2571 U18.2576 U18.5931 U18.3751 U18.3258 U18.3862 U18.2827 27144 U18.2331 13593 U18.3739 U18.3970 U18.4807 U18.2458 U18.3430 6984 A18.12285 21912 U18.3299 U18.3824 U18.3628 U18.2019 17575 U18.2032 U18.1723 U18.3805 12823 22850 U18.2447 U18.2448 U18.1413 22844 U18.3748 U18.3749 U18.6276 13987 U18.2485 U18.3763 6987 U18.3658 U18.3679 U18.3797 U18.3796 12786 U18.1143 U18.2136 U18.2380 U18.3757 U18.1776 U18.5475 U18.1313 29001 U18.1670 U18.3047 19441 U18.5123 U18.2952 U18.2911 U18.1681 U18.3385 U18.1559 U18.1159 U18.2652 U18.3344 U18.3617 16512 16643 U18.6734 17593 17595 28998 29062 U18.1769 U18.2271 7150 U18.7174 U18.3761 24628 U18.3584 U18.2164 U18.3619 U18.1148 U18.3392 U18.3867 U18.6134 13974 U18.4182 U18.3823 14564 U18.3245 U18.4495 15414 U18.4226 U18.2037 U18.2978 U18.2984 U18.4081 U18.2552 U18.2554 U18.2498 U18.2479 U18.4224 U18.4231 U18.4518 16487 16488 28543 U18.2736 14565 U18.3558 U18.3557 U18.3559 U18.5164 18610 18479 14545 19621 U18.5163 18612 U18.3548 19574 U18.1223 U18.4295 A18.12359 14009 14011 17006 U18.3063 13487 U18.1238 U18.3249 U18.1140 U18.7144 U18.2113 U18.2054 U18.2831 5933 U18.4600 U18.4229 U18.3813 U18.5101 U18.1170 U18.2794 U18.1391 U18.2806 U18.1842 16956 U18.4865 U18.8590 U18.1897 U18.2916 6393 17755 U18.3090 U18.1747 U18.3640 U18.3253 U18.3347 6397 U18.3729 U18.2487 U18.3973 U18.4011 U18.4189 22075 22076 U18.2474 14468 U18.4555 U18.3367 U18.3221 U18.3148 19539 U18.2445 U18.2793 19190 U18.5923 U18.1131 U18.2240 U18.5090 U18.1561 U18.2704 U18.1079 U18.2898 U18.2914 U18.1788 U18.1192 U18.4147 U18.2035 U18.3822 U18.2148 U18.5122 U18.1977 U18.1499 U18.3125 U18.6639 U18.3863 U18.6283 U18.6988 U18.7155 U18.7162 U18.7160 U18.6989 U18.6798 U18.3251 15363 14736 U18.1671 U18.7170 19582 U18.4849 U18.2854 U18.3644 U18.3029 U18.3254 U18.3295 U18.3618 U18.5769 U18.4432 13151 U18.3304 U18.2791 U18.3086 13812 U18.2707 U18.3358 U18.3246 17434 182705 28555 U18.2785 U18.2915 U18.2912 U18.3881 U18.1669 U18.4796 U18.3375 U18.2173 U18.1349 U18.2482 U18.2829 U18.3791 27518 U18.4257 U18.3868 U18.3361 U18.6643 U18.1340 U18.3450 U18.3224 U18.2214 U18.4897 U18.4015 U18.1399 U18.1601 U18.2715 U18.1455 U18.2940 U18.2687 7158 14731 U18.4186 15361 U18.4092 U18.2835 U18.7176 U18.1930 U18.4098 U18.4200 U18.4191 U18.4096 U18.2489 17160 U18.3043 U18.5478 U18.2206 U18.2426 U18.3376 17054 13628 U18.3756 U18.7147 U18.4360 U18.2472 U18.2583 U18.7163 U18.3198 12370 U18.1765 U18.2017 U18.4519 19559 U18.3776 U18.3394 U18.2689 13152 U18.1850 U18.2660 U18.12265 U18.2293 U18.7164 U18.2023 U18.3252 U18.1849 13156 U18.2598 U18.3677 13639 13111 U18.1615 U18.5086 15232 U18.3972 U18.3917 U18.4104 U18.1928 U18.4076 17985 U18.3762 U18.3233 U18.4573 U18.4355 U18.7113 26965 15072 17213 U18.2069 U18.2074 27077 27080 U18.2710 U18.3880 6802 U18.3716 U18.1128 21780 21846 28749 28752 28754 28759 U18.6834 U18.5065 15417 6839 U18.2590 U18.3627 U18.2798 U18.2737 U18.3792 U18.2094 U18.5082 U18.6484 U18.4509 U18.3120 U18.2146 U18.4858 U18.2355 U18.2153 U18.1541 U18.2557 U18.1415 U18.2016 U18.4882 U18.5128 U18.3025 5815 U18.6647 U18.2953 U18.2143 U18.2166 12563 6128 6315 U18.2174 17022 U18.3235 U18.2653 U18.2654 17123 28500 U18.1171 U18.2145 U18.2030 19251 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
• Recalling Firm/ Manufacturer: Roche Diagnostics Operations, Inc.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: Roche Customer Support Center; 317-521-4343
• Manufacturer 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.
• FDA Determined Cause: Software design
• Action: Roche issued Urgent Medical Correction Letter on 1/6/2021, Urgent Medical Device Correction TP-01190 and Distributor UMDC TP-01192 mailed via UPS Ground. For iCa++ results, rely on the numeric value and units on the printout, rather than the analyzer display. Investigate where a change in result reporting could impact patient management. Consult with the physician, pathologist, or Laboratory Director at your facility to determine specific clinical implications for your patients. **** UPDATE 2/7/22: Customer Bulletin TP-01454 Customer Bulletin-Roche 9180 Electrolyte Analyzer Discontinuation of ISE Calcium Electrode. Customer Bulletins (TP-01454 and TP-01455) informing customers about discontinuation of distribution of the iCa electrode in the US mailed on 2/7/2022. Roche has decided to discontinue sales and distribution of the ISE Calcium Electrode (catalog number 03110354180) from the U.S. market by 4/30/2022. Until the calcium electrode is discontinued, use the workaround in UMDC TP-01190 pg 4, to report Ionized Calcium (iCa++) results: Make sure that iCa++ values are reported in mmol/L instead of mg/dL or contact your Roche Services representative. The guiding arrow on the display can be wrong if the unit for iCa++ is set to mg/dL (Service Code MGL configured) and if a measured iCa++ value is lower than the normal range. If you use the unit mg/dL for iCa++, always use arrow information from the printout and not from the display. After the calcium electrode is no longer available, refer to the Roche 9180 Electrolyte Analyzer IFU for proper installation of electrodes, including the use of a dummy electrode, when not all ISE tests are required. This document is available on eLabDoc at the dialog.roche.com website. Please contact the Roche Support Network Customer Support Center at 1-800-526-2272 if you have questions.
• Quantity in Commerce: 1,214 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JFP and Original Applicant = AVL SCIENTIFIC CORP.