Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a Recalled by Quidel Corporation Due to The calibration for the affected batch of analyzers...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Quidel Corporation directly.
Affected Products
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.
Quantity: 482 units
Why Was This 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.
Where Was This Sold?
US Distribution
About Quidel Corporation
Quidel Corporation has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report