| Class 2 Device Recall iChemVELOCITY Automated Urine Chemistry System | |
Date Initiated by Firm | January 30, 2017 |
Date Posted | March 01, 2017 |
Recall Status1 |
Terminated 3 on August 19, 2017 |
Recall Number | Z-1384-2017 |
Recall Event ID |
76374 |
510(K)Number | K101852 |
Product Classification |
Automated urinalysis system - Product Code KQO
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Product | iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061.
The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose, bilirubin, urobilinogen, nitrite, leukocyte esterase, specific gravity, pH, ascorbic acid, color, and clarity. The iChem Velocity automated urine chemistry analyzer is intended to be used for in vitro measurement of various analytes in urine; it is intended for use only with the iChem Velocity urine chemistry strips |
Code Information |
Serial Number V01257 V02416 V02619 V01444 V02906 V02959 V03934, V03933 V02027, V02022, V04322 V03288 V03314 V02330 V02326 V02329 V02642 V02323 V03571 V03428 V02909, V01251 V01115 V02081 V02248 V03575 V03854 V03403 V04387 V04388, V01406 V01556 V04328 V04390, V01557 V04141 V02103 V01214 V04227, V02438 v01838 V04284 V02535 V02534 V02449 V04312 V02538 V02635 V02530 V02450 V02634 V02485 V02436 V02614 V02463 V02652 V02502 V02536 V02464 V02423 V02435 V02432 V02649 V02459 V02537 V03883 V01689 V03409, V03413 V01753, V01754 V02243 V02985 V02242 V03976 V03851 V03925 V04369 V02026 V03848 V01404 V02430 V03565 V02234 V02373 V01829 V02446 V02703 V01429 V02949 V02899 V04309 V01318 V01546 V04257 V03566 V01548 V01547, V02753 V01541 V01542 V02369, V03922 V01555 V02181 V02070 V01762 V04357 V04350 V04349 V04356 V04291 V01720 V03834 V02335 V03798 V01911 V01998 V03567 V04258 V03238 V04329 V03327 V01776 V01712 V03271 V01966 V01824, V02086 V01467 V03100 V01872 V04138 V02047 V02210 V03221 V03003 V03285, V03283 V02025 V01179 V01182 V03033 V02361 V01842 V02931 V01717, V04377 V03776 V01831 V03890 V01335 V01567,V01568 V03237 V03000 V02998 V03464 V02046 V01581 V01493 V03842 V04379 V01460 V04348 V03113 V01146 V01781 V04302 V01558 V04195 V03251 V04153 V02650 V03417 V02935 V02185 V01432 V02150 V03456 V02782 V02194 V02078 V02127 V02217 V02810 V03748 V01533 V02957 V01864 V04385, V01632, V01633 V04318 V03008 V03011, V03047 V02492 V01135 V01161 V02602 V02934 V01482 V02186 V02884 V02411 V01200 V03245 V01627 V01877 V01094 V01092 V01303 V01332 V02962 V03090 V04341 V03977, V03953 V01876 V01147 V03797 V02809 V03467 V03700 V03775 V04335, V03357 V02180 V01376 V01978, V01981 V01985 V03438 V01486 V02460 V01642 V01616 V03427 V01502 V03889 V03105, V03106, V03107 V02269 V01713 V03384 V03716 V02808 V01620 V03858 V01649 V02295, V02306 V02468 V01059 V04372 V01645 V03441, V03376 V02874 V03145 V01375 V03853 V04242 V01919 V01236 V03187 V03698 V03825 V01389 V02398 V02129 V03382 V03055 V02195 V02201 V02097 V02093 V02085 V03470 V01326 V01237 V01505 V03920 V02018 V02706 V01834 V01400, V01401 V03573 V03836 V03388 V02656 V02674 V02414 V02314 V02456 V04311 V02861 V01641 V03402 V02419 V02558 V01243 V01244 V02239 V01973 V01612 V03474 V01442 V01388 V02429 V01294 V01298 V02069, V01159 V01393 V04279 V03383 V01730 V01046 V01274 V02717 V03958, V01078, V03957 V01117, V01118 V01752 V02517 V02587 V02868 V04313, V02920 V02965, V02964 V02130 V03439 V01534 V01664 V02505 V01250 V04375 V03576 V04382 V01770 V01377 V01431 V01072 V01862 V02317 V02287 V01134 V03186 V02367 V03796 V02453 V04236 V01977 V04256 V03114 V01360 V02881 V01553, V04391 V02796 V02958 V02852 V03819, V03827 V04278 V01309 V01948 V04248 V03423 V01314 V01076 V02992 V01893, V01889 V01361 V03434 V03419 V01459 V01915 V03133 V01437 V03463 V03481, V04193 V03163 V04345 V03335 V02875 V02193 V01871 V01755 V03046 V03978 V03086 V03089 V03088 V03087 V03085 V02988, V02983, V02995 V01599 V02756 V02123 V01625 V02568 V03444, V03444 V01929 V03859 V04353 V03143 V01149 V03372 V02067 V01184 V04097 V01610 V04401 V03864 V01329 V01281 V02697 V02727 V02065 V04367 V02509 V03849 V01132 V02054, V02033 V02036 V03560 V01540 V02849 V02724 V02646, V02665 V02462 V02020, V02021, V02966 V03318 V01551 V01989 V03356 V02529 V01313 V02956, V02952 V03860 V04117 V03793, V03794 V04137 V02110 V01788 V03303, V01170 V03254 V01765 V03274, V03275 V03316, V03331 V03278 V03201 V03043 V02669 V01213 V03813 V01570 V02190 V03440 V03082 V01874 V01210 V01462 V03918 V03786 V03422 V02144 V03057 V02337 V03415 V01990 V03370 V03391 V03915, V03250 V03281 V02679, V01077 V01594 V04320 V04274 V01901 V03379 V03790 V02087 V02501 V04308 V02664 V02327 V02491 V02448 V01138 V02451 V03040, V03386 V01173 V02951 V04340 V03167 V01461 V03079 V03702 V04319 V04238 V04381 V02457 V02452 V01183 V01421 V02219 V02955 V01936, V01934 V01941 V01945 V02551 V03914 V01958 V02147 V01980 V04241 V04339, V01572, V01571, V01566 V03815 V03803, V03824 V03888 V01160 V01769, V04380 V02143 V03425 V02854 V02172, V02171 V02023, V02009 V02383, V02384 V02255 V02249, V02254 V02380, V02381 V02019 V02259, V02263 V02233 V01942 V02298, V02299 V01938 V02252, V02256 V02409 V02251 V02257, V02289, V02284 V04310 V02285, V01852 V02253 V04270, V04272 V03781, V03780 V04246, V04247 V04142, V04143 V02051, V01996 V04240, V04239 V04263, V04264 V04223, V04224 V04266 V01853 V03812, V03804 V02003 V02250 V02286 V02258 V02729 V02146, V02188 V02288, V02322 V02138, V02099 V02245, V02231 V02170, V02091 V02139, V02140 V04292, V04253 V03871, V03872 V03749 V03779 V02961 V02313 V03955 V04362, V04360 V03111 V02533 V01686 V01304 V01305 V01545 V02789 V01430 V03874 V03758 V03473, V03473 V02892 V01169 V02963 V02948 V02164 V04093 V03866 V03049 V02167, V02014, V03919 V04288 V01857, V01856 V02082, V01233 V01225 V02984 V01198 V02897 V02169, V02412 V02158 V01719 V02166 V04286 V02117 V01714 V01816 V01666 V03102 V01850 V02910 V01903 V01296, V03852 V01563 V01957 V03387 V03817 V01564 V03380 V03828 V02017, V02004 V02310 V01395 V03058 V01061 V02685 V02893 V03433 V02699 V01293 V02580 V04267 V03774 V02267 V03935 V03401, V03451 V01386 V02319 V02971 V04249, V01423 V01586 V01951 V01544 V02620 V01935 V01255, V01199 V01413 V02102 V03932 V02131 V01196 V03373 V03258 V01967, V02470 V03189 V03156 V03833 V04262, V04327, V04407 V03723 V02010, V01994 V01367 V01858 V04336 V02541 V01205 V04295 V04294 V02031 V01405 V03830 V01055 V02497 V01075 V01639 V02630 V04255 V01409 V01107 V01463 V01789 V01279 V01315 V01192 V01849 V03877 V01427 V01252 V04307 V04298, V01552 V02356 V03279 v02901 V01316 V02015 V03929, V03928 V01325 V01759 V02226 V01081 V03364, V01387 V03891 V02151 V03101 V04354 V04252, V01122 V03421 V03400 V03855 V02359 V01189 V01176 V03130 V02608 V02539 V03759 V02723 V02725 V02275 V01615 V01333 V01726 V01909 V04358 V03367, V01439 V02886, V02859 V02804 V03699 V03975 V03841 V02503 V03777 V01940 V03351 V01504 V02421, V01501 V01503 V02354 V03476 V02094 V03282, V03273 V02066 V03466 V01477 V04250 V02472 V04323 V01954 V01870 V01841 V01410, V04304 V01525 V01334 V01778 V02903, V02904 V02115, V02114 V02308 V01324 V01786, V01785 V02837 V02247 V04096 V02107 V02454, V01216 V03411 V01565 V02098 V04359 V02927 V01270 V03873 V03381 V04409 V01905 V03450 V03458 V01402 V03244 V04331 V04261 V01249 V03108 V01623 V01509 V02960 V02136 V03767 V03153 V01223 V02715 V03365, V01306 V03369, V03358 V03371, V01307 V04111 V03954 V02035 V02783 V02494 V04101 V02519 V04393 V02527 V03110 V01590 V01411 V02191 V01239 V02896 V02581 V01716 V03176 V01101 V03078 V04343, V01767 V03483 V03329 V03472 V04265 V03432 V03437 V04334 V01640 V03856 V01913 V03454 V03442 V01282 V03249 V03725, V01636 V03901 V02272 V02476 V02274 V02888 V03720 V02396 V03009 V04276 V02202 V04254 V04098, V04099 V03561 V02836 V02944 V02490 V04363, V04364, V01820, V04365, V01819 V02154 V03276 V02894 V01038 V01129 V01465 V02063 V02100 V02096 V02428 V03460, V03416 V02126 V01576 V01037 V02071 V04140 V04321 V02680 V02235 V01104, V04368 V02716 V03921 V01440 V01403 V02673 V02420, V02424 V01190 V01860 V01308 V02973 V04114, V04115 V04273 V02933 V03926 V04280 V01492 V02801 V04251 V01904 V02092, V02134 V01569 V02954 V01722, V01130 V03426 V04112 V01772 V02426 V02161, V02176 V03142 V01655 V02375 V02731 V03385 V02830, V01227 V02028 V02628 V02638, V02124 V02996 V02552 V01180 V03475 V01619 V01869 V01163 v03791 V02858 V02336 V01475 V03001 V01271 V02877 V01372, V01736,V02883 V04116 V02880 V02016 V04305 V02867 V01235 V02179 V02183 V02427 V04285 V02182 V04230 V04231 V04232 V04228 V04234 V04293 V04283 V02244, V01956 V03412 V02583 V04118 V03876 V02946 V02709 V01507 V01297 V01476 V03746 V02812 V03835, V03857 V03290 V02072 V01601 V01832 V01771 V03304 V01984 V01201 V01208 V03765 V03377 V04094 V03206 V01768 V03161 V02212 V03200 V03917 V03850 V03816 V03199, V03198 V03846 V03875 V01744, V04303 V01892 V01099 V02891 V03076 V01095 V03139 V01757 V02895 V01261 V03722 V02189 V04347 V03019 V01855 V02149 V04376 V04271, V04314 V01584 V03745 V04399 V02080 V01843, V01818 V02758 V02331 V03005 V01529 V04229 V01321 V01847 V02216 V03004 V02197 V02923 V02749 V01186 V03072 V03116 V03399 V01217 V02898 V01425 V01397 V02467 V04297 V03715, V03436 V02208 V04301 V02056 V01873 V03792 V03789 V01212 V03773 V02402 V01782 V01979 V02012 V01330 V02878 V04289, V04290 V03443, V03443 V03952 V02350 V02885 V03568 V04237, V04219 V01999 V03788 V02601 V02349 V02876 V01878 V01550 V01970 V01178 V02073 V02152 V03461 V02013, V04408 V04398, V04317 V01562 V01103 V02168 V03353 V03270 V01707 V04384, V04383 V02076 V01614 V01299 V02192 V02422 V02767 V04113 V02871 V04135 V03719 V03923 V03916 V02024 V02924, V02921, V02922 V03404 V01535 V02187 V02431 V01142 V03930 V01727 V02211 V03900 V01371 V02547 V02553 V03084 V03471 V03482 V03144 V01141 V03410 V04386 V01394 V03447 V03562 V03563 V01932 V03418 V03564 V03453 V02826 V03847 V01156 V03264 V01780 V03902 V03724 V04299, V02559 V01215 V02390 V02722 V02929 V02104 V04222 V01229 V02643 V01224 V03477 V02887 V01428 V03870 V03420 V01588 V02207 V04134 V02095 V02526 V02074 V01613 V03269 V01148 V02882 V02122, V03956 V01287 V01916 V01531 V01595 V03865 V01827 V04275 V04277 V01952 V01331 V02406 V01131, V01133 V01888 V02866 V01424 V02710 V02682 V02403 V01319 V02626 V03863, V02970 V03801 V01987 V01317 V02765, V02761 V03768 v01837 V03136 V02418, V02413 V01803 V03128 V03747 V02521 V01166 V01512 V01914, V01436 V01450 V01920, V01918 V03924 V01763 V01805 V03480 V01737 V01825 V04306 V02543 V04315 V01426 V03032, V03026 V01506 V02371, V02368 V01204, V01203 V01154 V01798 V01119 V03366 V02730 V02342 V01775 V01202 V01491 V03867 V01479 V01634 V01471 V04226, V01517 V01734 V02052 V01766 V01125 V02006, V02007 V01100 V01516 V01743 V01167 V01074, V02914 V01543 V02748 V04139 V01123 V02676 V01466 V01804 V03355 V02005 V03138, V03141 V01522 V01449 V01575 V03408 V04269, V04268 V03219 V02582, V02566 V04351, V01583, V04326 V02294 V04110, V04109 V01600 V01218 V03123, V02556 V02757 V01483 V01519, V04235 V01470 V02407 V03308 V03785 V03892 V01058 V01513 V03405, V03569 V02705 V02805 V01064 V01358 V03869 V03829 V01986, V01983 V02743 V02586 V02162 V01523 V04225 V02318 V02813 V01080, V01086 V01602 V01181 V02991, V01054 V01965 V04416, V04392, V01573 V02869 V01521 V04361, V04404 V01962 V01526, V04370 V03868 V01733 V01611 V02763 V01073, V01048 V01669 V01706, V01705 V01696, V01695 V01702, V01704 V02513 V01191 V01480 V01070 V01764 V04316, V01382 V03051, V02057 V01097 V02292 V01598 V02215 V01665, V01761 V02029, V03766 V01108 V03744 V02942 V01469 V04411, V04378 V01042 V04402 V01082 V04412 V02372 V01731 V01750 V01708 V01693, V02712 V01043 V01884 V03081, V01044 V02764 V01597, V01593 V01683 V02382 V01057 V01779 V03309 V01398, V04095 V01084, V01056 V03837, V01668 V04330, V02309 V01248, V02037 V01511 V01760 V01674 V01518, V04244 V02793 V04405 V02773 V01582, V04406 V01530, V04233 V03814, V01520 V03974, V03750 V01701, V01700 V02644 V03006 V01083, V01008 V02737 V01185 V01320 V01964 V01228, V02890 V02042, V04136 V01963 V03302 V01532, V04355 V01484, V01485 V01071 V02675 V03732 V02040 V01277 V01481 V02206, V02120 V01718 V01194, V01193 V01738 V01729 V02915, V04400, V01381 V01673, V04300 V03886, V01670 V01524 V04337, V02466, V04338 V03802 V04102 V01416 V02508 V01399 V03253 V02755 V03484, V04366 V01145 V03406, V03799 V03818 V03826 V02125 V01254 V04403 V02862 V03927 V02240 V02821 V02209, V03884 V02227 V02982 V02061, V02055 V04324 V02651, V02647 V03574, V01197 V02846, V02845 V02733 V02916, V01165 V03435, V03701 V01561 V01310, V01311 V03731 V02109 V03730 V01875, V01844 V01242, V01240 V04373 V04296, V03903 V03424 V01174 V03469 V02918, V02932 V03931 V02374 V01728 V02048 V03132 V01323 V02106 V01284 V03787 V02512 V02204 V01746, V01747 V03479 V01756 V01356 V03478 V02077 V03893 V03080 V04325 V03714 V01438 V03717, V03718 V03721 V01637, V01638 V04346, V02377 V01003 V03109 V03104 V02567 V02068 V02079 V02089 V02986 V02334 V04352 V02855 V04344 V01222 V03784 V01087 V01749, V01245 V04260 V02711 V01643 V04371 V03048 V01538 V03795 V03894 V04389, V01559 V03272 V01732 V02999 V03885 V01458 V02064 V03800 V04342 V01096 V02721 V03448 V03445 V03449 V03446 V01036 V02560, V02555 V02393, V02395 V01412,V03570 V03012 V02307 V03468 V04374 V01188 V01238 V01447, V01446 V04100 V02829, V02873, V02863 V03124 V02870, V01384 V03491, V03547 V02702 V02304 V03301 V02629 V03042 V02198, V02199, V03609 V02905 V03965 V03610 V03341, V02814, V02775, V03344, V02772 V02800 V03712, V02610, V02698, V02632 V02786, V02774, V03277, V02787, V03340 V02781 V02564 V02850 V03266, V03263 V03015 V02947 V03041 V02425 V02362 V03056 V04021
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Recalling Firm/ Manufacturer |
Beckman Coulter Inc. 250 S Kraemer Blvd Brea CA 92821-6232
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Manufacturer Reason for Recall | The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results. |
FDA Determined Cause 2 | Device Design |
Action | Beckman Coulter/Iris sent an Urgent Medical Device Recall letter dated January 30, 2017 to all affected customers to inform them that Iris International has determined that sample probe misalignment or bending on the iChemVELOCITY may lead to a remote possibility of false negative results due to inadequate strip dosing. Customers were informed that Inadequate dosing may lead to incorrect patient results which may not be detected by quality control, or to a delay in reporting results. Incorrect patient results might be observed as an unexpected discrepancy between instrument results and the patient's clinical picture. The greatest impact could occur when proteinuria is not detected. Customers were instructed to complete and return the enclosed Response Form within 10 days. Customers with questions were instructed to contact their local support representative:
Via our website, at http://www.beckmancoulter.com
By phone, call 800 854-3633 in the United States and Canada |
Quantity in Commerce | 3175 units total (1697 units in US) |
Distribution | Worldwide Distribution - US (nationwide) and internationally to Argentina, Australia, Austria, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Brunei, Canada, Chile, China, Columbia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Macau, Malaysia, Mexico, Moldova, Montenegro, Netherlands, New Zealand, Nigeria, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Republic and Venezuela. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = KQO
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