FDAFDA · Food and drugs·Recall number Z-1384-2017
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
Published March 8, 2017 · Recall initiated: January 30, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter Inc.
- Distributor
- 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.
- Lot
- 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 V0
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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