Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used wi...
FDA Recall #Z-1183-2018 — Class II — December 15, 2017
Product Description
Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use.
Reason for Recall
The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which may lead to a failure when calibration is first performed. There may also be e remote possibility that incorrect qualitative test results for patient samples near the assay cutoff may be reported.
Recalling Firm
Quidel Corporation — San Diego, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
482 units
Distribution
US Distribution
Code Information
Serial Numbers: 29003956, 29004025, 29004086, 29004072, 29004188, 29004150, 29004229, 29004127, 29004232, 29004204, 29004256, 29004362, 29004155, 29004290, 29004329, 29004347, 29004350, 29004353, 29004370, 29004390, 29004396, 29004415, 29003381, 29003814, 29004183, 29004259, 29004263, 29004281, 29004317, 29004343, 29004205, 29004209, 29004001, 29004062, 29004077, 29003915, 29004036, 29004057, 29003979, 29004085, 29004144, 29004267, 29004322, 29003960, 29003991, 29004163, 29004190, 29004330, 29003992, 29004033, 29003987, 29004306, 29004325, 29004332, 29004066, 29004335, 29004373, 29004430, 29004223, 29004299, 29003999, 29004026, 29004069, 29003811, 29004164, 29004189, 29004226, 29003923, 29004160, 29004206, 29004181, 29004194, 29003584, 29004172, 29004014, 29004046, 29004352, 29004354, 29004376, 29004285, 29004377, 29004016, 29004047, 29004054, 29004196, 29003970, 29004173, 29004372, 29004252, 29004287, 29004311, 29004159, 29004356, 29004381, 29004089, 29004092, 29004270, 29004331, 29004357, 29004413, 29003578, 29004250, 29003967, 29004235, 29004319, 29003928, 29004096, 29004262, 29004280, 29004273, 29004302, 29004284, 29004278, 29004241, 29004305, 29004067, 29004125, 29004228, 29004265, 29004097, 29004303, 29004342, 29004349, 29004286, 29004098, 29004108, 29004128, 29004130, 29003947, 29004037, 29003961, 29004408, 29003636, 29003990, 29004240, 29004215, 29003738, 29004093, 29004070, 29003635, 29004006, 29004011, 29004015, 29004061, 29004073, 29004088, 29004106, 29004142, 29004148, 29004161, 29004162, 29004351, 29004391, 29004418, 29004146, 29004170, 29003978, 29004123, 29004208, 29004249, 29004315, 29004407, 29004111, 29004116, 29004243, 29004469, 29004511, 29004535, 29004548, 29003977, 29004187, 29004018, 29004039, 29004052, 29004009, 29003952, 29002222, 29004230, 29003957, 29003965, 29004359, 29004346, 29004361, 29004369, 29004378, 29004387, 29004411, 29004393, 29004441, 29004443, 29003769, 29003840, 29004147, 29004156, 29004176, 29004184, 29004186, 29004192, 29004202, 29004203, 29004210, 29004214, 29004216, 29004219, 29004222, 29004225, 29004227, 29003980, 29004048, 29004064, 29004304, 29004423, 29004283, 29004295, 29004297, 29004298, 29004310, 29004392, 29004224, 29004231, 29004558, 29004076, 29004165, 29004414, 29004274, 29004292, 29004300, 29004314, 29004318, 29004041, 29004101, 29004334, 29004380, 29004074, 29003886, 29004023, 29004081, 29004402, 29003892, 29004211, 29003936, 29004003, 29004404, 29003703, 29004153, 29004191, 29004213, 29004100, 29004040, 29004333, 29004336, 29004367, 29004291, 29004338, 29004288, 29004365, 29004239, 29004337, 29004486, 29004504, 29004508, 29004519, 29004524, 29003891, 29002538, 29004242, 29004174, 29003971, 29004012, 29003617, 29003975, 29003973, 29004145, 29003700, 29004133, 29004275, 29004326, 29004339, 29004307, 29004233, 29004257, 29004282, 29004296, 29004309, 29004323, 29004084, 29004234, 29004238, 29004254, 29004260, 29004261, 29004316, 29004447, 29004503, 29004533, 29004545, 29004552, 29004143, 29004197, 29004151, 29002356, 29002457, 29003946, 29003948, 29004017, 29004045, 29004095, 29004102, 29004104, 29004107, 29004110, 29004134, 29004137, 29004152, 29004157, 29004022, 29004382, 29004434, 29004027, 29003989, 29003995, 29004035, 29004087, 29004090, 29003993, 29004105, 29004114, 29004279, 29003688, 29004131, 29004139, 29004374, 29004360, 29004368, 29004375, 29004371, 29003731, 29004397, 29004328, 29004388, 29004010, 29004177, 29004348, 29004355, 29004366, 29004383, 29004399, 29004422, 29004425, 29004432, 29004440, 29004294, 29002598, 29003969, 29004112, 29004117, 29004412, 29004416, 29004421, 29003893, 29003895, 29003997, 29004030, 29004060, 29001731, 29004327, 29004345, 29004398, 29004405, 29004410, 29004419, 29004427, 29004439, 29004444, 29004384, 29004236, 29004272, 29004293, 29004308, 29004321, 29004251, 29004289, 29004080, 29004136, 29004271, 29004386, 29003389, 29004042, 29004078, 29003981, 29004083, 29004004, 29004051, 29004024, 29004068, 29004258, 29004409, 29004217, 29004417, 29004389, 29003313, 29003530, 29004198, 29004385, 29004029, 29004247, 29004266, 29004220, 29003954, 29004091, 29004124, 29004140, 29004401, 29004406, 29004438, 29004126, 29004400, 29004320, 29003988, 29004075, 29003976, 29004058, 29004113, 29004121, 29004158, 29003983, 29004094, 29004049, 29004071, 29003984, 29004005, 29004028, 29004044, 29004055, 29004065, 29004154, 29004180, 29004195, 29004420, 29004269, 29004344, 29004268, 29003607, 29004379, 29004403, 29004031, 29004246, 29004312, 29004301, 29004313, 29004255, 29004277, 29004264, 29004244, 29004245, 29002389, 29003275, 29003675, 29004115, 29004175, 29004179, 29004200, 29004207, 29004218, 29003996, 29004020, 29004019, 29003931, 29003998, 29003949, 29003966, 29004008, 29003994, 29003968, 29002280, 29003985, 29004043, 29003896, 29003986, 29004120, 29004433, 29004358
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.