| 2023-05-24 |
Class II
|
Ongoing |
Z-2255-2023 |
NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and… |
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Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into… |
| 2023-05-15 |
Class III
|
Ongoing |
Z-2093-2023 |
NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and o… |
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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 1… |
| 2022-05-13 |
Class II
|
Ongoing |
Z-1251-2022 |
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900 |
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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 nega… |
| 2022-02-18 |
Class II
|
Ongoing |
Z-1000-2022 |
NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: Ne… |
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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 (NeuMoD… |
| 2022-01-21 |
Class II
|
Ongoing |
Z-0738-2022 |
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 a… |
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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 whe… |
| 2021-05-04 |
Class II
|
Terminated |
Z-1978-2021 |
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100 |
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There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays. |