Company: Dade Behring, Inc
Date of Enforcement Report: 1/30/02
Class: II
PRODUCT
Dimension Clinical Chemical Analyzer XL/RxL/ARx with software revision 5.2, Recall # Z-0433-02.
REASON
Instructions to software revision are missing a step.
CODE
Revision 5.2
The following serial numbers are involved in the recall: 971807, 973002, 970457, 973278, 970598, 970454, 970049, 971979, 973242, 970864, 973218, 970219, 973498, 970152, 950208, 971645, 970300, 950207, 972376, 970919, 970066, 970521, 971949, 972903, 971202,973145, 972464, 973143, 971229,971939, 973140, 973100, 973083, 971966, 970480, 950209, 970037, 972495, 972628, 971098, 971660, 972850, 971102, 971052, 972117, 972173, 970705, 972590, 971625, 971526, 973150, 970599, 972904, 973014, 970880, 970327, 971414,
970561, 971200, 971953, 972373, 971813, 972137, 971845, 973074, 972040, 971830, 970481, 972222, 970173, 971023, 972664, 970836, 990281, 971226, 970471, 970860, 970588, 973080, 973190, 973192, 972273, 973195, 970639, 973193, 973191, 950446, 970033, 972363, 970550, 970249, 972425, 970164, 970649, 973406, 971640, 971650, 971679, 972471, 972474, 972596, 970382, 972176, 972270, 971260, 950165, 971721, 972884, 972451, 950341, 971701, 970518, 972232, 970824, 971241, 972301, 970464, 970035, 971388, 973285, 972743, 973128, 971310, 970847, 990267, 990270, 973257, 971277, 972581,
971794, 973208, 971838, 950380, 972338, 970572, 971094, 973153, 971131, 972368, 970697, 972441, 972962, 973206, 970087, 972079, 973213, 970978, 973365, 973325, 950108, 950421, 973028, 972393, 973339, 990257, 950286, 971653, 972911, 972269, 972663, 970359, 970692, 970337, 972920, 970343, 970889, 970041, 970622, 970969, 971422, 971641, 970808, 970890, 972378, 971655, 971293, 970324, 970560, 971442, 970222, 972790, 971057, 971271, 970261, 970242, 970048, 970214, 971121, 970477, 950170, 970056, 972572, 970289, 970702, 971711, 972494, 970032, 970654, 971025, 970754, 973509,
970821, 990184, 972369, 972321, 971384, 971461, 971027, 971937, 972559, 970128, 971194, 971570, 971602, 950176, 971833, 970220, 972266, 970282, 970874, 973290, 970929, 970358, 971133, 973228, 971666, 971592, 970790, 970111, 971196, 971129, 973088, 971901, 972438, 973428, 973036, 971413, 971572, 971500, 990139, 990186, 971841, 972459, 971429, 990221, 973072, 973268, 972364, 973320, 971993, 972260, 971930, 972528, and 971829.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dade Behring, Inc. Newark, DE, by telephone on Nov. 11 and by letter on Nov. 19, 2001. Manufacturer: Dade Behring, Inc. Brookfield, CT.Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
256 sets.
DISTRIBUTION
Nationwide.