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.
Enforcement
- Recall Number
- Z-1183-2018
- Event ID
- 79271
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Quidel Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 4, 2018
- Initiation Date
- December 15, 2017
- Classification Date
- March 26, 2018
- Termination Date
- October 21, 2019
- Address
- 10165 McKellar Ct, San Diego, CA, 92121-4201, United States
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.
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.
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
US Distribution
482 units