NeuMoDx Molecular Inc
Complete recall history across all FDA and CPSC categories — 6 total recalls
NeuMoDx Molecular Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (6)
FDA medical device enforcement actions by NeuMoDx Molecular Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| May 24, 2023 | NeuMoDx Cartridge-used for extraction, purification, amplification and detect... | Top label on some of the NeuMoDx cartridges within these lots may have been i... | Class II |
| May 15, 2023 | NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS... | Potential for lot number discrepancies between the test strip packaging and t... | Class III |
| May 13, 2022 | NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900 | There is a potential for reduced analytical sensitivity for samples in the 1x... | Class II |
| Feb 18, 2022 | NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems ... | Potential for false positive results for SARS-CoV-2 in identified lots of car... | Class II |
| Jan 21, 2022 | NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed und... | A risk for product contamination was identified for the affected product lot.... | Class II |
| May 4, 2021 | NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx... | There is a potential for false positive results when certain lots of cartridg... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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