NeuMoDx Molecular Inc
NeuMoDx Molecular Inc appears in FDA public data with 6 recalls, 2 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2255-2023, Class II) was initiated on May 24, 2023. Its most recent 510(k) clearance was granted on December 22, 2023.
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 2
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2255-2023 | Class II | NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on | May 24, 2023 |
| Z-2093-2023 | Class III | NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, | May 15, 2023 |
| Z-1251-2022 | Class II | NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900 | May 13, 2022 |
| Z-1000-2022 | Class II | NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the fo | February 18, 2022 |
| Z-0738-2022 | Class II | NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distrib | January 21, 2022 |
| Z-1978-2021 | Class II | NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, | May 4, 2021 |