Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

Detalles del retiro

Fabricante

Beckman Coulter Inc.

Distribuidor

Worldwide Distribution - US Nationwide in the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Bosnia-Herzegovina, Botswana, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Ethiopia, France, Germany, Gibraltar, Greece, Guam, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Korea, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Pakistan, Palestinian Territory, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom, United States including Puerto Rico, Venezuela, and Vietnam.

Lote

Serial No. 504489 502713 503114 503824 504400 504373 501946 507570; 503285, 800337, 700292 505091 509407 509349 509793 509801 509764 509768 509671 509628 509670 509690, 509705 509724 509800 509771 509744 509746, 509735 509668 509799 509626 509797 509669 509765 509790 509798 509739 509736 509769 509287 504104 509063 509256 509511 503600 505722 502105 504597 503503 504557 505476 504095 504060 503183 505154 506131 509267 509524 500646 509532 501760 509369 509514 509177 800135 509313 504619 800074 504591, 508910, 508912, 508907 509373, 509304 506566 508920 505811 508914, 508917 509625 502796 508933, 508934 509291 509634, 509635 509530, 509588 509787, 509788, 509783 509433, 509437, 509662, 509663, 509660, 509659, 509658 509715 509657 508916, 508566, 509344, 509526, 509424, 509461, 509459, 509466, 509062, 509197, 509200, 509195, 509196, 509201, 509199, 509605, 509604, 509571, 509585, 509567, 509569, 509568, 509566, 509579, 509570 508887, 509489, 509542, 509538, 509541, 509645, 509647, 509652, 509649, 509648, 509642, 509644 509341, 509346 508885, 508891, 509781, 509782, 509770 509026, 509020, 509025, 509027, 509028, 509021 509651, 509784 509194, 509190 509713, 509710 509175 509560, 509557, 509556, 509558 509553, 509554 509219, 509237, 509236, 509233, 509231, 509234, 509238, 509212, 509240, 509230, 509208, 509216, 509232, 509214 509535 509072, 508994, 508981, 508990 509531, 509417, 509398, 509759 509089 509050, 508991 508884, 508888, 508870, 509075, 509074, 509076, 509069, 509147, 509145, 509155 509442, 509443 509622 509107 508937, 509697, 509698 509821, 509810 509512, 509169, 509174, 509170, 509695 509610, 509620, 509613 509355, 509471, 509468, 509699, 509700, 509702, 509703 509517, 509520, 509664, 509665, 509666 509637 508954, 508996, 509203, 509210, 509205, 509209 509401, 509202, 509780, 509779 509423 ,509426, 509806, 509804, 509812, 509807, 509805 509561 508940 509564 509141 509142 509156 509507 509598 509023 509045 509090 509342 509217 509098 509104 509359 509415 509586 509539 509005 509002 509487 509345 508872 509404 509405 508961 509456 509061 508995 509220 509211 509052 509540 509469 509154 508992 509362 508976 508883 508875 509022 509448 509410 509436 508882 508971 509485 509483 509159 508998 508922 508874 509043 509017 509446 509227 509215 509397 509066 509091 509711 509106 509631 508957 509223 508986 509440 509431 509418 509229 508974 509445 509225 509425 509422 508879 508972 509048 509137 509133 509478 509482 509488 509082 509081 509619 509218 509000 509470 509108 509343 508876 508997 509457 509109 508894 509235 509084 509595 509008 509492 509044 509079 509412 509708 509709 509224 508869 509226 509064 509420 509013 508983 509411 509379 509399 508985 509712 509480 508953 509476 509228 509559 509083 509653 508987 509434 508864 509058 508902 508893 508975 509172 509655 508988 509105 509331, 509332 505348, 504964, 503973, 503803 509363 509347 509365 505980 509357 509484 509350 507659 509361 502352 504206 502973 507942 504121 501988 501981 504243 504320 508080, 507913, 508662 509704, 509707 509528 503193, 800313 501985 509167 504816 503459 509479 504132 509148 504423 504337 509018 504406 509533 504249 509335 504990 508909 503084 504415 508588 508589 502899 505130 509261 509271 508944 503700 508370 505951 509413 509036 509438 501685 509577 506229 505444 506246 800237 506188 504526 503954 507118 502219 509516 500172 509500 502246 700287 504019 800020 508968 505082 800085 501846 504717 501986, 502495 505178 503525 509326 501672 508555 506177, 506081 509059 500039 800022 501896, 500039 509789 505041 503212 501489 502545 501480 502836 509518 509029 504139 503467 501272 505281 501431

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States