COVID-19 Test Strips Recalled for Lot Number Label Discrepancy
NeuMoDx SARS-CoV-2 test strips from lot 123909 have conflicting lot numbers between the package label and barcode label that the instrument reads.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with no reported adverse events or patient harm. The issue is a labeling discrepancy affecting inventory and product tracking—a minor documentation problem without reported illness or injury.
Plain-English summary
NeuMoDx Molecular Inc has recalled 1,086 NeuMoDx SARS-CoV-2 Assay test strips (REF 300800) from lot 123909 due to a labeling discrepancy. The lot number printed on the test strip packaging does not match the lot number encoded on the barcode label that is read by the testing instrument. The instrument registers the barcode as lot number 123910 instead of 123909.
The affected test strips were distributed nationwide in the states of Florida, Michigan, New Mexico, New York, Tennessee, and Texas. The lot expires December 8, 2023.
This discrepancy creates a potential for errors in lot number tracking and product identification when the testing instrument processes the test strips.
The recalled product
- Product
- 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). RE
- Manufacturer
- NeuMoDx Molecular Inc
- Hazard
- labeling-error
- product-tracking-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 10814278021264 Lot Number: 123909 Exp. Date: 08-Dec-2023
Distribution
Distributed nationwide across the United States.
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