Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of Recalled by NeuMoDx Molecular Inc Due to Potential for lot number discrepancies between the test...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact NeuMoDx Molecular Inc directly.
Affected 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
Quantity: 1,086 test strips
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About NeuMoDx Molecular Inc
NeuMoDx Molecular Inc has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report