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FDASeptember 5, 2024device

NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468

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

The hazard

Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.

What to do

FDA enforcement status: Ongoing

Brands named

luminex molecular diagnosticsluminexluminex molecular

Recall history

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

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