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NeuMoDx Molecular Inc FDA Recalls
6 recalls on file across devices, 0 of them Class I and 5 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 andClass IIMay 24, 2023Top label on some of the NeuMoDx cartridges within these lot |
| NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oClass IIIMay 15, 2023Potential for lot number discrepancies between the test stri |
| NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900Class IIMay 13, 2022There is a potential for reduced analytical sensitivity for |
| NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeClass IIFeb 18, 2022Potential for false positive results for SARS-CoV-2 in ident |
| NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 aClass IIJan 21, 2022A risk for product contamination was identified for the affe |
| NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100Class IIMay 4, 2021There is a potential for false positive results when certain |