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Recall Observatory FDA recall evidence

Device product

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

Z-0828-2022

November 16, 2021

Class II

Product summary

Firm
Roche Molecular Systems, Inc.
Event
Event 89643
Status
Ongoing
Classification
Class II
Quantity
14 units
Official record key
device-enforcement:Z-0828-2022

Official wording

Reason: 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.

Code information: UDI: 07613336100097; Serial Numbers: 16333, 16454, 16688, 16695, 16871, 16914, 17048, 17266, 19924, 18094, 18323, 18357, 17116, 17086

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of CO, IL, IN, KY, MI, NC, and TX. The countries of Cyprus, Spain, and Hong Kong.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.