NeuMoDx Molecular Inc: 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

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the states of FL, MI, NM, NY, TN, TX. Quantity: 1,086 test strips Lot/code info: GTIN: 10814278021264 Lot Number: 123909 Exp. Date: 08-Dec-2023

UPC codes

10814278021264

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.