Home / Brands / NeuMoDx Molecular
NeuMoDx Molecular Recalls
6 recalls on record · July 7, 2021 to August 9, 2023 · Medical Devices
Recalls by year
21
22
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 9, 2023Medical DevicesFDA
NeuMoDx Molecular Inc recalls NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and
Hazard: 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
July 12, 2023Medical DevicesFDA
NeuMoDx Molecular Inc recalls NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and o
Hazard: 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.
June 15, 2022Medical DevicesFDA
NeuMoDx Molecular Inc recalls NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
Hazard: 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.
May 4, 2022Medical DevicesFDA
NeuMoDx Molecular Inc recalls NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: Ne
Hazard: 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
March 16, 2022Medical DevicesFDA
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 a
Hazard: 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.
July 7, 2021Medical DevicesFDA
NeuMoDx Molecular Inc recalls NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
Hazard: There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.