Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution

ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. || The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives. || ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This reagent is intended for use on the ABX PENTRA 400 Clinical Chemistry Analyzer.

All Lots

Clinical Chemistry and Clinical Toxicology Devices

1

No

US Nationwide Distribution.

ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 || Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium).

All lot numbers; Software Version(s): Application versions below (V5.14 & V2.12) for Pentra 400 and Versions below (V1.07) for Pentra C400

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution: US (nationwide) and to countries of: Bulgaria, Burma, Cameroon, Djibouti, France, Gabon, Germany, Italy, Lebanon, Mali, Mauritania, Poland, Portugal, Romania, Saudi Arabia, South Africa and Thailand.

ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 || The device is intended for use in conjunction with certain materials to measure a variety of analytes.

Lot/Serial# PML0937

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide in the US, including the states of CA, MI, IN, FL, and GA. Center Recall Depth is Retail.

ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2

Product Control/Lot #SK28.99

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide Distribution --- including states of TX, UT, and VA.

ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge); List Number: 07L02-01; manufactured by Inpecco SpA, Segrate (MI), Italy.

all serial numbers

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide: including state of UT.

Abbott ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; Abbott Laboratories, Abbott Park, IL 60064

Serial Numbers: ABT 042, ABT 055, ABT 037, ABT 016, ABT 041, ABT 046, ABT 035, ABT 040, ABT 039, ABT 033, ABT 028, ABT 011, ABT 006 and ABT 007.

Clinical Chemistry and Clinical Toxicology Devices

1

No

International Distribution -- Spain, Italy, the United Kingdom, Sweden, Switzerland, the Netherlands, France, Canada and Scotland.

ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.

All Serial Numbers.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide:Distributed to hospitals/laboratories in IL, PA, TN, TX, UT, VA and WV.

Abbott, ACCELERATOR Device Manager (ADM); List Number: 08H74-01; Abbott Laboratories, Abbott Park, IL

All fielded instruments.

Clinical Chemistry and Clinical Toxicology Devices

Nationwide and Canada

Access 2 immunoassay side of LXi 725

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 502309 509374, 503292, 503484 501135 504260 504536 506062 504611 508943 500061 504025 501953 505222 501372 506788 508694 509400 505144 503187 503496 505994 502412 502180 507584 504558 500403 506181 501610 503995 501746 504016 507063 500478 504757 503551 509101 504613 502019 502423 501348 509617 505898 508900 509116 503400 508895 508823 507795 501076 508945 505647 501375 501366 504167, 503888 500490 500533 505008 503921 501743 500436 508941 508928 503585 509375 501085 504108 504181 700119 500787 500117 500775 503792 505866 504923 506009 502266 500901 501770 505220 504665 503681 502918 501156 500579 505477 500300 503469 504035 504590 504270 503166 504384 504190 509416 508821 505465 503463 509033 505289 501739 508778 506813 503095 504670 502909 500589 501680 508599 502130 500357 502566 501095 509388, 509115 504803 508786 509386 500648 505294 509204, 509207, 509575, 509786, 509785 508862 501227 500836 504648 506101 501414, 501698, 502626 505107 800171 800553 506987 509314 509352 800220 508905 504885 509130 509274 509371. 509370 509103 509049 508970 504357 507755 509070, 509067 509047, 509046 509093, 509094 800387 506626 509686 500531 502548 505118 501916 509552 505110 502776 504203 503038 502706 506368 505519 502399 502962 502591 503521 502311 505494 509543 502658 502473 504006 508818 502670 500629 503180 502880 508939 503696 502976 503659 503176 502304 505419 505549 505287 501983 504503 500539 505941 502206 500494 508863 505004 504504 509795 508938 509279 505814 503814 509315 509316 507864 509092 508813 509603 508903, 508901 509288 509006 508849 502969 507741 508808 509596 509444 508602 509121 508899 506034, 509706 503333 501991 700075 501117 505061, 508807, 507733, 507476, 509041 501314 508568, 508134 500686 508140 503235 502410 504052 502239 508805, 507728, 506416, 509486 508963 509298, 509430, 509428 504430, 503270, 502846 501367, 501034, 500914 509073 501286 509584 509656, 509761 504781 506674, 505930, 507401, 506091, 505972 503371 501900 403732 500402 505889, 505912, 505340 506243 506012 502653 505071 506039 502108 506032 505284 505253 502261 502608 504153 504169 503867 503208 503107 503331, 502834 505229 503252 502177 502109, 502643, 502501 502117 500620 503495 508955 504832 504225 505573 504055 505996 504450 504562 504096, 504798, 503680, 503770, 503253 500603 509302, 509300, 509301, 509037, 509040, 509038, 509039, 509035, 509125, 509126, 509127, 509716 509153, 509701, 509714 508354, 509643, 509640, 509639, 509641, 700320 501479 506359 508861 504403 509338 505526 504246 505188 503708 800340 505335 503607 505928 503173 505503 800158 508401 508374 507319 800357 504359 506634 504870 504587, 506238 502464 501149 500954 508918 509012 509693 509136 509143 509024 509525 509527 509594 509323 509467 508775 507436, 506696, 509280 ,509281, 509439, 509435, 509589, 509688, 509755 509114 508915 508969 509158 509146 508921 508479 509161 509574 509010 508960, 508956, 508959, 508965, 508999, 509150, 509144 508926 509004 508932 508967 509334, 509333, 509149 508913 509152 508925 509330 508951 505784 508107 509309 508966 509592 509687 509685 509682, 509679 508935 508824 508919 509384 508896 509394 509380, 509385, 509391, 509389, 509387, 509390, 509393, 509408, 509395, 509751, 509752, 509750, 509749 509392 509011 509009 509278 509277 507223, 509689, 509747 509402 509447 508878 509014 509007 509003 509001 506364 508877 509100, 509722, 509721, 509728, 509730, 509727, 509726, 509723, 509725, 509729, 509811, 509813, 509818 508906 509099, 508886 508911 509097 506176, 506141, 506027 508355 504032 501232 502186 502205 503610 509473 502164 504352 509065, 509068 509521 700132 500879 509376, 503571 501294 502729 501295 500880 500659 502368 501440 502035 509419 509515 509451 500231 500507 502079 509504 505351 504116 500335 504114 509582 509460 509583 800292 502427 506597 509618 509732 509163 506595 509414, 509409, 509030, 509031, 509032, 509222, 509221, 509621, 509623 504128 509290 505970 501446 504394, 506720, 506686, 509295 509138 504835 504323, 508892, 509243, 509317, 509183, 509239, 509242, 509165 505547, 509244, 509248, 509307, 509308, 509306, 503599 501405 504412 508897 504305 504729 506833 504353 504379, 504256, 505768, 505116, 506699 508814 508889, 509245, 509696 505439 502047 500484 505010 508950 502305 507757 501643 505087 500855 500480 509529 509720 509753 500973 500840 508973 800373 500994 506231, 506160 506258, 506199 700290, 700236 507380, 502480 504815, 508228 505927, 502362 700201, 700177 507379, 506515 508124, 700270 502116 509019 509441 507693 502512 509111 509129 508936 503091 800036 509760, 509762 509718 509283, 800809 800372 509312, 509310 509602 506252 502940 509537 509717 509263 509358 509270 509453 506766 509672 509016 509694 509803 509311 800650 505704 509377 508931 505298, 509513 509481 509499 509549 509508, 509576 509421 509284, 509454 509547, 509551 507848 509320 509354 509151 509015 506093 509122 508800 508881 509120 509339 509296 509188 500530 509173 509676 509429 502289 509615 509123 509646 509654 509472 509124 508029 509452 508964 509766 800804 505215 509464 509677 509135 509673 509282 509383 509113 500143, 509490 508930 509600 800774 509054 700190 509088 509368 509285 509609 506477 509817 509275 509182 509734 509458 508923 507846 509794 509292 509053 509550 800178 501309 509522 509572 509340 506236 509455 509773 505932 503495 503400 509611 509611, 509606 509573 506417 509096 506586 509757 505124 509266 506211 506155 507050 509250 502537 506536 508946 800205 509327 509692 509189 509071, 509077 509179 509192 509198 509591, 509590 509181, 509180 502844 505574 502839 504213 509777, 509774, 509776, 509775, 509778 508430 502841 502853, 509809 509477 700271 509495 509562 508349 508898 509102 507024 509178 504550 503369 509616 505557 508993 509497 509259 509738 509767 509493 509505 509276 509674 509128 509254 509624 509772 509057 509247 509299 509348 509607 509328 508982 508929 509251 509260 509255 509272 509548 509273 508904 508984 509661 509055 800878 800001 509494 800697 508908 505308 509132 505939 508942 509563 507594 508871 509353 505892 509187 505643 509206 509650 504826 507522 505995 509360 509286 507156 509257 509509 507695 509249 509581, 509796 508978 800694 509110 508859 505170 503542 509095 509519 508962 503214 509680 502008 509745 509164 509325 509820 504635 505843 509819, 501974 509808 509731, 509733 509268 504905 509056 508977 504232 509119 500921 700306 506663 506318 509465 509367 509378 509737 509246, 509241 509289 800515, 505991 509265 506694 509112 509051 509253 509293 509501 508890 509632 509523 503138 509503 509496 509502 509593 509060 509319 509681 800877 509087 509085 509086 509678 509318 509802 509297 509336 506678 508958 509193, 509191 504461 800674 509382 508949 506166 509366 509463 509822 509396 504472 509599 509171, 509166 501439 503511 509491 509763 800394 509140 504490 509118 509719 509351 509691 509042 509630 509252, 509258 509184 508356 509474 509185 509601 505342 509329 509356 502631 509269 509636 509534 507774 506072 509667 500350 509372 509578 500580 509162 504061, 509741 507872 509176 509186 508948 509262 509381 509303 509792 509337 500360 509546, 509555 501984 800270 509264 509758 500425 505890, 800238 506050 502358 509321, 509324, 509322, 509475, 509545, 509544, 509427, 509080, 509078, 508980, 509213, 509139, 509131, 509134, 509627, 509633, 509816, 509815, 509814 508989

Clinical Chemistry and Clinical Toxicology Devices

1

No

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.

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.

Serial Numbers:  508801, 508802, 508803, 508804, 508805, 508806, 508807, 508810

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide distribution: US (nationwide) in the state of: TX and countries of: Colombia, Hong Kong and Korea.

Access 2 Immunoassay System, Part Number: 81600N || The Access 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.

All fielded instruments.

Clinical Chemistry and Clinical Toxicology Devices

Nationwide and Canada

Access 2 Immunoassay System

Access 2 Immunoassay Systems Catalogue numbers: 81600N, 386220, A69186, A12900, A56158, A65531UniCel DxC 600i SYNCHRON Access Clinical System Catalogue numbers: A25640, A25638, A25637, A25635, A25656, A25634An in vitro diagnostic device (IVD)ARTG Number: 177999

Clinical Chemistry and Clinical Toxicology Devices

Lot Numbers: 911158, 911581, and 917631

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide and Canada

Access Immunoassay Systems AFP QC, Part Number: 33219 || The Access AFP QC is intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprotein (AFP) using the Access Immunoassay Systems.

Peristaltic Pumps with Serial Numbers above 22349820

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide, and in Canada

Access and Access 2 Immunoassay System

All versions are affected.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide Distribution & Canada

Access Immunoassay Systems, Part Number: 81600 ; Access 2 Immunoassay Systems, Part Number: 81600N; || Synchron LXi 725; UniCel DxI 800 Access Immunoassay Systems, Part Number: 973100; UniCel DxI 600 Access Immunoassay Systems, Part Number A30260; || UniCel DxC 600i, Part Number: A25656; UniCel DxC 660i, Part Number: A64871; UniCel DxC 860i, Part Number: A64935; UniCel DxC 880i, Part Number: A59102; SYNCHRON Access Clinical || Systems || The Access/DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found in human body fluids. Function of the Peristaltic Pump: to aspirate unbound material from reaction vessels and to move waste from vacuum jar into waste bottle through associated tubing within the Access Immunoassay System.

Lot number 215173

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide and Canada

ACCESS Estradiol Reagent Test System

Lots 323171; 416110; 417703; 419534

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide and Canada

Access Immunoasay Systems Digoxin Reagent

Part Number: A19889, Access APF Wash Buffer REF 81907  Lot Number: 714944, 717432, 720808, 821426, 823659.  Part Number: A45144, Access APF Wash Buffer REF A16792  Lot Number: 714939, 717433, 720811, 821429, 823661.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution-USA (nationwide) and the country of Canada.

Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access 2. || Part Number: A15518, Access 2 APF Wash Buffer REF 81907, || Part Number: A45142, Access 2 APF Wash Buffer II REF A16792. || The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration found in human body fluids.

Part Number: A54376, Synchron LXi 725 APF,  Lot Number: 722633, 823669. Part Number: A54377, Synchron LXi 725 AAF Lot Number: 722632, 823671.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution-USA (nationwide) and the country of Canada.

Access Immunoassay Systems Assay Protocol File (APF) Software versions for Synchron LXI 725. || Part Number: A54376, Synchron LXi 725 APF, || Part Number: A54377, Synchron LXi 725 AAF. || The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration found in human body fluids.

All Serial Numbers

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution--USA (nationwide) and Puerto Rico and the countries of Algeria, Angola, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Lebanon, Liechtenstein, Malaysia, Mayette, Mexico, Morocco, Nambia, Netherlands, New Zealand, Norway, Philippines, Poland,, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Venezuela and Vietnam.

Access Immunoassay Systems Part Number: 81600 || Access 2 Immunoassay Systems Part Number: 81600N || Access Immunoassay Systems LXi 725 Part Number: 386200 || Subsequent Product Codes: JGS || The Access/DxI 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.

DxI software versions: 4.2 and 4.2.1. For labeling see UniCel DxI Operator's Guide. Part Number: 387262G

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- United States and Canada.

UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access Clinical Systems with Dxl System Software versions 4.2 or 4.2.1. || In vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentrations found in human body fluids.

All Serial Numbers.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- United States, Afghanistan, Algeria, Angola, Antigua and Barbuda, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Mexico, Morocco, Myanmar, Namibia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestinian Territory, Panama, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, Yemen, Zambia, and Zimbabwe.

Access Immunoassay Systems, Part Number 81600N & 81600N. || An in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found in human body fluids.

Part Number: A54378, UniCel DxC 600i APF,  Lot Numbers: 722631, 823677. Part Number: A54379, UniCel DxC 600i AAF, Lot Numbers: 722630, 823675.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution-USA (nationwide) and the country of Canada.

Access Immunoassay Systems Assay Protocol File (APF) Software versions for UniCel DxC 600i Systems. || Part Number: A54378, UniCel DxC 600i APF, || Part Number: A54379, UniCel DxC 600i AAF. || The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration found in human body fluids.

Part Number 81901, Lot Numbers: 13181168-13341170.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - USA (nationwide) and Internationally to Canada, Japan, India, Hong Kong, Guatemala, China, Brazil, Brunei Darussalam, Costa Rica, El Salvador, JordanMalaysia, Mexico, Panama, Philippines, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Venezuela, and Viet Nam.

Access Immunoassay Systems Reaction Vessels. || The Access 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.