cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Reported: April 6, 2022 Initiated: November 16, 2021 #Z-0828-2022
Product Description
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Reason for Recall
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.
Details
- Recalling Firm
- Roche Molecular Systems, Inc.
- Units Affected
- 14 units
- Distribution
- 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.
- Location
- Branchburg, NJ
Frequently Asked Questions
What product was recalled? ▼
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190. Recalled by Roche Molecular Systems, Inc.. Units affected: 14 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 6, 2022. Severity: Moderate. Recall number: Z-0828-2022.
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