medical Class III Updated 2023-07-12

NeuMoDx Molecular Inc recalls NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative

Recalled 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). REF Number: 300800


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN: 10814278021264 Lot Number: 123909 Exp. Date: 08-Dec-2023
View official government recall

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