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FDAJuly 5, 2020device

DYNEX Agility, Agility Analyzer, Model No. 67000

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control from another assay's SmartKit will be used instead of the correct control, which may lead to delayed patient results.

What to do

FDA enforcement status: Ongoing

Brands named

dynex technologiesdynex

UPCs

05060456180058

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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