Quidel Corporation recalls Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunoflu…

Recall date

December 15, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1183-2018

FDA classification

Class II

Brand / firm

Quidel Corporation

Sold / distributed

US Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.