medical Class II Updated 2022-04-06

Roche Molecular Systems, Inc. recalls cobas LiatSystem, respiratory virus panel nucleic acid assay

Recalled Product

cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190

Hazard / Issue

Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 07613336100097; Serial Numbers: 16333, 16454, 16688, 16695, 16871, 16914, 17048, 17266, 19924, 18094, 18323, 18357, 17116, 17086
View official government recall

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