FDA recall Z-1978-2021

NeuMoDx Molecular Inc · Class II · device

Product

NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100

Reason for recall

There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.

Distribution

Worldwide distribution.

Key facts

Status
Terminated
Initiation date
2021-05-04
Report date
2021-07-07
Termination date
2022-06-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Ann Arbor, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1978-2021