FDA-Device2023-07-12Class III
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
NeuMoDx Molecular Inc
Hazard
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.
Sold states
US Nationwide distribution in the states of FL, MI, NM, NY, TN, TX.
Affected count
1,086 test strips
Manufactured in
1250 Eisenhower Pl, N/A, Ann Arbor, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2093-2023Don't want to check this manually?
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