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[Recalled] cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190 — Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza… | FDA 2021-03-25

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

Productcobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
Brand / manufacturerRoche Molecular Systems, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1414-2021
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date25 March 2021
EAN / barcode07341920190

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Roche Molecular Systems, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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