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FDAJuly 20, 2016device

OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.

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

The hazard

Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.

What to do

FDA enforcement status: Terminated

Brands named

orasure technologiesorasure

Recall history

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

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