Roche cobas Liat Analyzer Respiratory Virus Panel Recall
Roche is recalling the cobas Liat Analyzer respiratory virus panel due to invalid or false positive results for SARS-CoV-2 and Influenza A/B.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are typically scored as 4 (Severe), especially when involving diagnostic errors that could lead to incorrect clinical management, even if specific hospitalization reports are not detailed in the snippet.
Plain-English summary
Roche Molecular Systems, Inc. is recalling the cobas Liat Analyzer: respiratory virus panel nucleic acid assay system (Catalog Number: 07341920190). The recall involves 5,430 units in the United States and 1,528 units outside the US, distributed nationwide and worldwide.
The recall was initiated because the assay, used under Emergency Use Authorization, produced invalid or false positive results for one or more targets, including SARS-CoV-2, Influenza A, and Influenza B. These abnormal results were associated with abnormal PCR growth curves.
Healthcare facilities and laboratories using this specific assay system should stop using the affected units and contact Roche for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
- Manufacturer
- Roche Molecular Systems, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial ID numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Roche Molecular Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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