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Quidel Corporation recalls Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immun
Recalled April 4, 2018 · FDA recall Z-1183-2018 · Quidel
Hazard
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. · FDA Class II
Units
482 units
Sold at
US Distribution
Description
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.
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.
Manufacturer(s)
Quidel Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →