Recall Z-2093-2023 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
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 lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). REF Number: 300800
| Date | Jul 5, 2023 (initiated May 15, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling mix-ups |
| Action | QIAGEN issued Urgent: Medical Device Correction Letter (PROM-22155-001) on 5/15/23 via email to Lab Director/Manager, Medical Director, Risk Manager,Safety Officer. Letter states reason for recall, health risk and action to take: If you have remaining stock of SARS-CoV-2 Test Strips LOT 123909 REF 300800, do not use it. Please contact QIAGEN Technical Service for a free-of-charge replacement. " Dispose of the product LOT 123909 in accordance with your national and local safety and environmental regulations. " Review this notice with your laboratory/medical director. Important: Forward this inf |
| Quantity | 1,086 test strips |
| Distribution | US Nationwide distribution in the states of FL, MI, NM, NY, TN, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.