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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT i2000SR Processing Module

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  Class 2 Device Recall ARCHITECT i2000SR Processing Module see related information
Date Initiated by Firm December 12, 2006
Date Posted February 07, 2007
Recall Status1 Terminated 3 on September 24, 2007
Recall Number Z-0416-2007
Recall Event ID 36996
510(K)Number K983212  
Product Classification in vitro diagnostic - Product Code JJE
Product ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; Temperature Controller Board Part #78560-109; distributed by Abbott Laboratories, Irving, TX.
Code Information 1SR03771 1SR03653 1SR03823 1SR03720 1SR03565 1SR03839 1SR03835 1SR03708 1SR04077 1SR03719 1SR03621 1SR03626 1SR04030 1SR03618 1SR03570 1SR04031 1SR03891 1SR04033 1SR03562 1SR04048 1SR03698 1SR03567 1SR03813 1SR03868 1SR03747 1SR03615 1SR03826 1SR04032 1SR03752 1SR03772 1SR03983 1SR03623 1SR03520 1SR03553 1SR03680 1SR03713 1SR03725 1SR03746 1SR03757 1SR03168 1SR03530 1SR03533 1SR03537 1SR03538 1SR03569 1SR03676 1SR03862 1SR03832 1SR03678 1SR03679 1SR03819 1SR03484 1SR03588 1SR03778 1SR03673 1SR03518 1SR03510 1SR03825 1SR03767 1SR03754 1SR03659 1SR03844 1SR03809 1SR03880 1SR03882 1SR03705 1SR03596 1SR03549 1SR03590 1SR03514 1SR03571 1SR03513 1SR03612 1SR03859 1SR03489 1SR03524 1SR03522 1SR03852 1SR03853 1SR03740 1SR03662 1SR03564 1SR03517 1SR03741 1SR03663 1SR03830 1SR03884 1SR03576 1SR03768 1SR03786 1SR03769 1SR03774 1SR03775 1SR03886 1SR03531 1SR03577 1SR03486 1SR03821 1SR03541 1SR03759 1SR03921 1SR03671 1SR03760 1SR03692 1SR03501 1SR03582 1SR03583 1SR03516 1SR03723 1SR03528 1SR03790 1SR03700 1SR03896 1SR03608 1SR03729 1SR03487 1SR03593 1SR03632 1SR03620 1SR03619 1SR03464 1SR03597 1SR03598 1SR03600 1SR03482 1SR03485 1SR03601 1SR03827 1SR03674 1SR03745 1SR03779 1SR03807 1SR03818 1SR03883 1SR03890 1SR03242 1SR03481 1SR03499 1SR03503 1SR03525 1SR03547 1SR03559 1SR03568 1SR03594 1SR03595 1SR03603 1SR03605 1SR03606 1SR03622 1SR03625 1SR03629 1SR03633 1SR03634 1SR03677 1SR03707 1SR03712 1SR03721 1SR03770 1SR03777 1SR03782 1SR03783 1SR03789 1SR03795 1SR03801 1SR03808 1SR03840 1SR03842 1SR03848 1SR03849 1SR03850 1SR03854 1SR04063 1SR04064 1SR04065 1SR04066 1SR04068 1SR04069 1SR04070 1SR04071 1SR04072 1SR04074 1SR04084 1SR04085 1SR04086 1SR04087 1SR04091 1SR04092 1SR04093 1SR04094 1SR04098 1SR04101 1SR04102 1SR04112 1SR04116 1SR04119 1SR04120 1SR04122 1SR04123 1SR04124 1SR04126 1SR04127 1SR04128 1SR04129 1SR04130 1SR04131 1SR04132 1SR04134 1SR04137 1SR04138 1SR04139 1SR04140 1SR04141 1SR04145 1SR04149 1SR04111 1SR04121 1SR04125 1SR04133 1SR03544 1SR03578 1SR03924 1SR03946 1SR03953 1SR04136 1SR04146 1SR04147 1SR04148 1SR04153 1SR04154 1SR03627 1SR03952 1SR03997 1SR03766 1SR03534 1SR03806 1SR04023 1SR03695 1SR03664 1SR03976 1SR03580 1SR04055 1SR03816 1SR03684 1SR03773 1SR03631 1SR03824 1SR03628 1SR03505 1SR03682 1SR03515 1SR03507 1SR03820 1SR03498 1SR03765 1SR04045 1SR03967 1SR04089 1SR03828 1SR03846 1SR04028 1SR04002 1SR04076 1SR03635 1SR03660 1SR04113 1SR04114 1SR03793 1SR04001 1SR03656 1SR04034 1SR03694 1SR03874 1SR04118 1SR03589 1SR04150 1SR03714 1SR03738 1SR03909 1SR04081 1SR03800 1SR03805 1SR03756 1SR04097 1SR03502 1SR03906 1SR04151 1SR03555 1SR03607 1SR03617 1SR03812 1SR03814 1SR03831 1SR03152 1SR04156 1SR04162 1SR04166 1SR04155 1SR04160 1SR03554 1SR03558 1SR03560 1SR03591 1SR03613 1SR03655 1SR03717 1SR03718 1SR03722 1SR03726 1SR03727 1SR03735 1SR03776 1SR03791 1SR03794 1SR03799 1SR03822 1SR03836 1SR03841 1SR03843 1SR03845 1SR03851 1SR03855 1SR03857 1SR03894 1SR03904 1SR03962 1SR03971 1SR03982 1SR03986 1SR03994 1SR03998 1SR04012 1SR04013 1SR04018 1SR04019 1SR04021 1SR04024 1SR04035 1SR04052 1SR04067 1SR04073 1SR04075 1SR04079 1SR04080 1SR04090 1SR04104 1SR04107 1SR03731 1SR03661 1SR03743 1SR03834 1SR03733 1SR03734 1SR03585 1SR03490 1SR03811 1SR03748 1SR03810 1SR03804 1SR03654 1SR03637 1SR03732 1SR03523 1SR03636 1SR03860 1SR03792 1SR03614 1SR03798 1SR03552 1SR03667 1SR03657 1SR03847 1SR03683 1SR03497 1SR03545 1SR03701 1SR03574 1SR03575 1SR03630 1SR03535 1SR03892 1SR03803 1SR03458 1SR03573 1SR03536 1SR03761 1SR03493 1SR03561 1SR03864 1SR03867 1SR03572 1SR03556 1SR03960 1SR03675 1SR03581 1SR03539 1SR03763 1SR03641 1SR03665 1SR03604 1SR03699 1SR03829 1SR03557 1SR03500 1SR03670 1SR03511 1SR03526 1SR03579 1SR03703 1SR03755 1SR03509 1SR03750 1SR03586 1SR03587 1SR03666 1SR03669 1SR03611 1SR03551 1SR03616 1SR03638 1SR03642 1SR03643 1SR03644 1SR03645 1SR03646 1SR03647 1SR03648 1SR03649 1SR03650 1SR03651 1SR03658 1SR03728 1SR03730 1SR03817 1SR03833 1SR03838 1SR03863 1SR03865 1SR03869 1SR03870 1SR03873 1SR03879 1SR03897 1SR03899 1SR03900 1SR03856 1SR03858 1SR03866 1SR03872 1SR03876 1SR03877 1SR03878 1SR03887 1SR03888 1SR03889 1SR03907 1SR03908 1SR03910 1SR03916 1SR03920 1SR03922 1SR03923 1SR03926 1SR03927 1SR03945 1SR03957 1SR03958 1SR03961 1SR03972 1SR03973 1SR03974 1SR03978 1SR09803 1SR03981 1SR03989 1SR03995 1SR04000 1SR04004 1SR04005 1SR04006 1SR04007 1SR04008 1SR04011 1SR04015 1SR04016 1SR04017 1SR04025 1SR04026 1SR04027 1SR04029 1SR04036 1SR04039 1SR04040 1SR04041 1SR03764 1SR03542 1SR03668 1SR03690 1SR03903 1SR03762 1SR03788 1SR03913 1SR04106 1SR03563 1SR04056 1SR03685 1SR03527 1SR03521 1SR03895 1SR04022 1SR03912 1SR04053 1SR04105 1SR03918 1SR03901 1SR04096 1SR03893 1SR03610 1SR03984 1SR03744 1SR04038 1SR04044 1SR04014 1SR03992 1SR03751 1SR03780 1SR03691 1SR03702 1SR03693 1SR03787 1SR03686 1SR03602 1SR03975 1SR03546 1SR03736 1SR03529 1SR03932 1SR03672 1SR03711 1SR03599 1SR03977 1SR03540 1SR03881 1SR03739 1SR03715 1SR03709 1SR03724 1SR03543 1SR03696 1SR03688 1SR03689 1SR03697 1SR03710 1SR03784 1SR03797 1SR03917 1SR03942 1SR03987 1SR04009 1SR04020 1SR04043 1SR04050 1SR04082 1SR04083 1SR04088 1SR04095 1SR04099 1SR04115 1SR04135 1SR03753 1SR04117 1SR03914 1SR03749 1SR03758 1SR03898 1SR03875 1SR03532 1SR03550 1SR03796 1SR03802 1SR03592 1SR03624 1SR03742 1SR04037 1SR04010 1SR04046 1SR04100 1SR04042 1SR04060 1SR03979 1SR03999 1SR03885 1SR03566 1SR03491 1SR03492 1SR03504 1SR03506 1SR03512 1SR03704 1SR03508 1SR03815 1SR03609 1SR03687 1SR03781 1SR03584 1SR03496 1SR03985 1SR03991 1SR03519 1SR03639 1SR03640 1SR03706 1SR03716 1SR03737 1SR04047 1SR04049 1SR04051 1SR04057 1SR04058 1SR04059 1SR04061 1SR04062 1SR03652 1SR03993 1SR04003 1SR04054 1SR04103 1SR04108 1SR04109 1SR04110 1SR03785 1SR03871 1SR03919 1SR03988 1SR03990 1SR03488 1SR03495 1SR03681 1SR03480
Recalling Firm/
Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 152020
Irving TX 75038
Manufacturer Reason
for Recall
The re-designed ARCHITECT Temperature Controller Board has been identified as being susceptible to electromagnetic interference (EMI) in the laboratory. This can cause a board reset condition, stopping temperature control function of the board. Situation does not stop analyzer operation and does not generate an error condition alerting operator when condition occurs.
FDA Determined
Cause 2
Action Firm contacted consignees by telephone and fax with instructions to verify proper functioning of the Temperature Controller Board starting December 13, 2006.
Quantity in Commerce 648 units.
Distribution Worldwide, including USA, Argentina, Australia, Brazil, Canada, Chile, Columbia, Dominican Republic, Germany, Hong Kong, Jamaica, Japan, Korea, Mexico, New Zealand, Peru, Puerto Rico, Singapore, Taiwan, Thailand, Trinidad, Tobago, Uruguay, and Venezuela.
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 = JJE and Original Applicant = ABBOTT LABORATORIES