Neumodx Molecular, Inc.
United StatesFDA applicant, unverified
- Devices
- 22
- FDA recalls
- 65 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Neumodx Molecular, Inc. makes
Neumodx Molecular, Inc. manufactures molecular diagnostic assays, including the NeuMoDx CT/NG Assay 2.0 for detecting *Chlamydia trachomatis* and *Neisseria gonorrhoeae*, and the NeuMoDx GBS Assay for *Streptococcus agalactiae* detection. These tests are designed for use in clinical laboratories to identify bacterial infections in patient samples.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded via the 510(k) pathway. Products are listed in the FDA’s regulatory database, and the company operates from the United States.
Catalogue
Search and filter all 22 devicesCompany details
- DUNS number
- 078667309
- [email protected]
- Phone
- +1(734)372-2617
FDA recalls
FDA recall records list 6 recalls initiated by Neumodx Molecular, Inc., the earliest on 2021-05-04 and the most recent on 2023-05-24. By recorded status: 5 ongoing and 1 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 1
- 2022 3
- 2023 2
- 2024 0
- 2025 0
- 2026 0
2023
- 24 May 2023 Z-2255-2023 Class II Ongoing Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The misplaced label may interfere with the module s optics performance, thereby increasing the risk for false positive results
Full distribution text
- 15 May 2023 Z-2093-2023 Class III Ongoing 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.
- 24 May 2023 Z-2255-2023 Class II Ongoing Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The misplaced label may interfere with the module s optics performance, thereby increasing the risk for false positive results
2022
- 13 May 2022 Z-1251-2022 Class II Ongoing There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.
Full distribution text
- 18 Feb 2022 Z-1000-2022 Class II Ongoing Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used in conjunction with assays containing SARS-CoV-2 targets (NeuMoDx" SARS-CoV-2 Test Strip Cat #300800 and NeuMoDx" Flu A-B/RSV/SARS-CoV-2 Vantage Assay Cat #300900) result incorrect management of patients
Full distribution text
- 21 Jan 2022 Z-0738-2022 Class II Ongoing A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.
- 13 May 2022 Z-1251-2022 Class II Ongoing There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.
2021
- 4 May 2021 Z-1978-2021 Class II Terminated There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.
Frequently asked questions
How many devices does Neumodx Molecular, Inc. have in the registry?
The registry currently lists 22 devices for Neumodx Molecular, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neumodx Molecular, Inc.'s devices?
Among its 22 most recently registered devices, Neumodx Molecular, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (20 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Neumodx Molecular, Inc.'s devices fall under?
Among its 22 most recently registered devices, the classes recorded for Neumodx Molecular, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Neumodx Molecular, Inc.?
FDA recall records list 6 recalls initiated by Neumodx Molecular, Inc., the most recent initiated on 24 May 2023. 5 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Neumodx Molecular, Inc. in the registry?
The most recently registered devices listed for Neumodx Molecular, Inc. include NeuMoDxTM Lysis Buffer 3 400600, NeuMoDxTM Wash Reagent 400100, NeuMoDx™ Lysis Buffer 5 400900 and NeuMoDx™ Viral Lysis Buffer 401600.