Reported Apr 6, 2022 · Ongoing

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

Roche Molecular Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Roche Molecular Systems, Inc. · 1080 US Highway 202 S · Branchburg, NJ · 08876-3733

Is this the product you have?

  • cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Lot codes and dates
  • UDI07613336100097
  • Serial Numbers
    • 16333
    • 16454
    • 16688
    • 16695
    • 16871
    • 16914
    • 17048
    • 17266
    • 19924
    • 18094
    • 18323
    • 18357
    • 17116
    • 17086
Amount recalled
14 units

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:08 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.