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FDAMarch 5, 2024device

QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests

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

The hazard

There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.

What to do

FDA enforcement status: Ongoing

Brands named

quidel

UPCs

30014613336754

Recall history

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

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