Recall Z-2093-2023— NeuMoDx Molecular Inc
Class III · Ongoing
Class III FDA medical device recall by NeuMoDx Molecular Inc, initiated 2023-05-15. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..
- Recalling firm
- NeuMoDx Molecular Inc
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2023-05-15
- Firm location
- Ann Arbor, MI, United States
Product description
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.