Device 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
Z-2093-2023
Product summary
- Event
- Event 92490
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 1,086 test strips
- Official record key
device-enforcement:Z-2093-2023
Official wording
Reason: 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.
Code information: GTIN: 10814278021264 Lot Number: 123909 Exp. Date: 08-Dec-2023
Distribution pattern: US Nationwide distribution in the states of FL, MI, NM, NY, TN, TX.
Derived failure modes
-
Unknown
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.