FDA-Device2021-07-07Class II
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
NeuMoDx Molecular Inc
Hazard
There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.
Sold states
Worldwide distribution.
Affected count
620 cases (29,760 cartridges total)
Manufactured in
1250 Eisenhower Pl, N/A, Ann Arbor, MI, United States
Products
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1978-2021Don't want to check this manually?
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