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