Ann Arbor, MI, United States
NeuMoDx Molecular Inc recalls
6 recalls recorded since 2018, most recently on 24 May 2023. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)5
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 24 May 2023
- Reason
- 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
- Distribution
- US Nationwide Distribution to states of: Kansas, Florida, Texas, Ohio, New York, Michigan, Pennsylvania; and OUS (Foreign) to countries of: AT, BE, CH, DE, ES, FI, FR, GB, IT, LV, PL, RO, SE
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2255-2023
- NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx System(s) Ref: 100100
Ongoing Class III Medical devices
- Recall started
- 15 May 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of FL, MI, NM, NY, TN, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2093-2023
- NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals s
Ongoing Class II Medical devices
- Recall started
- 13 May 2022
- Reason
- 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.
- Distribution
- Domestic distribution to FL, NY, MD, PA, VA, MI, TN, NM. Foreign distribution to AT, AU, BE, CH, DE, FI, FR, GB, GR, HK, ID, IT, LT, NL, SA, SE, and SI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1251-2022
- NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
Ongoing Class II Medical devices
- Recall started
- 18 February 2022
- Reason
- 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
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of OH, MO, VA, MI, MI, FL, MD, IA, NY, MO and the countries of Italy, Germany, Switzerland, Sweden, Netherlands, Finland, Spain, United Kingdom, Belgium, Austria, Hong Kong, France, Denmark, Slovenia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1000-2022
- NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test Strip (REF 300800) NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip (REF 30
Ongoing Class II Medical devices
- Recall started
- 21 January 2022
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of FL, MD, MI, NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0738-2022
- NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot
Terminated Class II Medical devices
- Recall started
- 4 May 2021
- Terminated
- 21 June 2022
- Reason
- There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1978-2021
- NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.