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

Recalled July 7, 2021 · FDA recall Z-1978-2021 · NeuMoDx Molecular

Hazard

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

Units

620 cases (29,760 cartridges total)

Sold at

Worldwide distribution.

Description

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

Product

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

Manufacturer(s)

NeuMoDx Molecular Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →