NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Syste ...



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
Components:
Recall Date:    Feb 18, 2022
Mfg:
NeuMoDx Molecular Inc
Mfg Country:
United States
Recall ID:    89846
Product ID:    192674
Enforcement Date:    May 4, 2022
Last Published:    Apr 22, 2022

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Emert Number:    Z-1000-2022
Emert Status:    Notified