Events

Recall of Device Recall Sofia 2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Quidel Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79271
  • Event Risk Class
    Class 2
  • Event Number
    Z-1183-2018
  • Event Initiated Date
    2017-12-15
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161800
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Devices detecting influenza A, B, and C virus antigens - Product Code PSZ
  • Reason
    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.
  • Action
    Quidel sent and Urgent Product Recall letter dated December 15, 2017. The letter instructs the user to discontinue use of the device until new firmware can be installed. For further questions, please call (800) 874-1517.

Device

Device Recall Sofia 2
  • Model / Serial
    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
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution
  • 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.
  • Manufacturer
    Quidel Corporation

Manufacturer

Quidel Corporation
  • Manufacturer Address
    Quidel Corporation, 10165 McKellar Ct, San Diego CA 92121-4201
  • Manufacturer Parent Company (2017)
    Quidel Corporation
  • Source
    USFDA