medical Class II Updated 2021-07-07

NeuMoDx Molecular Inc recalls NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoD

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Distribution: Worldwide distribution.
Lot/Code Info: GTIN: 10814278020274; Lot Numbers: 106629 106630 106631 106632
View official government recall

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