Z-1183-2018Class II

Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based...

Name: Z-1183-2018 Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based...
Creator: Quidel Corporation
Published: 2017-12-15
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2017-12-15 / Terminated / root cause: software

FDA source

Quidel Corporation began a recall of 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... on 2017-12-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1183-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-15
Posted: 2018-03-26
Terminated: 2019-10-21
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: 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.
Product code: PSZ Devices Detecting Influenza A, B, And C Virus Antigens
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.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
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.
Quantity in commerce: 482 units
Distribution: US Distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1183-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1183-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-26

Product code PSZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)