NeuMoDx Molecular recalls
5 official recalls and safety alerts involving NeuMoDx Molecular since 2022-03, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with NeuMoDx Molecular or the relevant agency.
- 2023-08-09
USNeuMoDx Molecular Inc recalls NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96…
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…
FDA · DeviceNeuMoDx Molecular IncUS Nationwide Distribution to states of: Kansas, Florida, Texas, Ohio, New…Official notice →- 2023-07-12
- US
NeuMoDx Molecular Inc recalls NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs…
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…
FDA · DeviceNeuMoDx Molecular IncUS Nationwide distribution in the states of FL, MI, NM, NY, TN, TX.Official notice → - 2022-06-15
- US
NeuMoDx Molecular Inc recalls 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 - 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…
FDA · DeviceNeuMoDx Molecular IncDomestic distribution to FL, NY, MD, PA, VA, MI, TN, NM. Foreign distribution…Official notice → - 2022-05-04
- US
NeuMoDx Molecular Inc recalls NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test…
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…
FDA · DeviceNeuMoDx Molecular IncWorldwide distribution - US Nationwide distribution in the states of OH, MO,…Official notice → - 2022-03-16
- US
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 assay strips in…
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.
FDA · DeviceNeuMoDx Molecular IncUS Nationwide distribution in the states of FL, MD, MI, NY.Official notice →