NeuMoDx Molecular Inc recalls NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and o…

Recall date

May 15, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2093-2023

FDA classification

Class III

Brand / firm

NeuMoDx Molecular Inc

Sold / distributed

US Nationwide distribution in the states of FL, MI, NM, NY, TN, TX.

Why it was recalled

Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip that is read by the instrument for LOT 123909 of NeuMoDx SARS-CoV-2 Test Strips (REF 300800). The instrument registers the non-human readable text as lot number 123910 from the barcode label.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). REF Number: 300800