6 results
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50ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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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
FDA Recall
Open, Classified
·NeuMoDx Molecular Inc·Product code PPM·May 24, 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 suspected of COVID-19 by their healthcare provider (HCP). REF Number: 300800
FDA Recall
Open, Classified
·NeuMoDx Molecular Inc·Product code QJR·May 15, 2023
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 #, and expiration date.
FDA Recall
Open, Classified
·NeuMoDx Molecular Inc·Product code QJR·January 21, 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 300900) NeuMoDx Laboratory Developed Tests (LDTs) for SARS-CoV-2 RNA detection Note: Results for targets other than SARS-CoV-2 are not impacted by this Urgent Medical Device Correction Ref. Number: 100100
FDA Recall
Open, Classified
·NeuMoDx Molecular Inc·Product code QJR·February 18, 2022
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
FDA Recall
Open, Classified
·NeuMoDx Molecular Inc·Product code QLT·May 13, 2022
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
FDA Recall
Terminated
·NeuMoDx Molecular Inc·Product code QJR·May 4, 2021