NeuMoDx Molecular Inc recalls
Every recall we track for NeuMoDx Molecular Inc — 6 in all, from 2021–2023 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from NeuMoDx Molecular Inc peaked in 2022 (3); 6 since 2017.
All FDA recall records for NeuMoDx Molecular Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 1 | 2 | 0 | 3 |
| 2023 | 0 | 0 | 2 | 0 | 2 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled NeuMoDx Molecular Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All NeuMoDx Molecular Inc recalls
6 shown- Lower riskMedical device
NeuMoDx Molecular Inc recalls NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288
NeuMoDx Molecular Inc recalls specific cartridges for PCR tests due to incorrect labeling that may cause false positive results. Affected lots include 117514, 117524, and 117528.
NeuMoDxMay 24, 2023 - Lower riskMedical device
NeuMoDx Molecular Inc recalls NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and
NeuMoDx recalls SARS-CoV-2 test strips with lot number 123909 due to potential mismatch between packaging and barcode labels, causing incorrect lot registration in instruments.
NeuMoDxMay 15, 2023 - Lower riskMedical device
NeuMoDx Molecular Inc recalls NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
NeuMoDx recalls Flu A-B/RSV/SARS-CoV-2 Vantage Test Strips (Model 300900) due to potential false negatives in certain samples, which could lead to undetected infections and delayed treatment.
NeuMoDxMay 13, 2022 - Lower riskMedical device
NeuMoDx Molecular Inc recalls NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays:
NeuMoDx recalls specific SARS-CoV-2 test cartridges that may cause false positive results, leading to incorrect patient management. Affected lots include 115424-115431.
NeuMoDxFeb 18, 2022 - Use cautionMedical device
NeuMoDx Molecular Inc recalls NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6
NeuMoDx recalls specific lots of its Flu A-B/RSV/SARS-CoV-2 Vantage Test Strips due to contamination risks that may cause false positive SARS-CoV-2 results.
NeuMoDxJan 21, 2022 - Lower riskMedical device
NeuMoDx Molecular Inc recalls NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
NeuMoDx Molecular Inc recalls specific model cartridges for in vitro diagnostics due to potential false positive results with certain assays. Affected lots: 106629-106632.
NeuMoDxMay 4, 2021
NeuMoDx Molecular Inc recall questions
How many recalls has NeuMoDx Molecular Inc had?
6 recalls from NeuMoDx Molecular Inc are on record with U.S. safety agencies, from 2021–2023.
What is the most recent NeuMoDx Molecular Inc recall?
NeuMoDx Molecular Inc recalls NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288, dated May 24, 2023. Every NeuMoDx Molecular Inc recall is listed on this page, newest first.
What should I do if I have a recalled NeuMoDx Molecular Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new NeuMoDx Molecular Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.