Cobas Liat respiratory virus analyzer units recalled for false Influenza B results
Roche is recalling 14 Cobas Liat analyzer units due to detector noise causing false positive Influenza B results. Affected units were distributed in seven U.S. states and three countries.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall involves no reported illnesses or injuries. The hazard is potential diagnostic error (false positive test results) without actualized harm, meeting the criteria for Moderate severity.
Plain-English summary
Roche Molecular Systems, Inc. is recalling 14 Cobas Liat analyzer units with consistently high noise levels in the amber detector used for Influenza B detection. The affected units are identified by UDI 07613336100097.
The high detector noise increases the probability of false positive Influenza B test results. This diagnostic inaccuracy could lead to incorrect test interpretation and potentially inappropriate clinical decisions.
The 14 affected analyzer units were distributed in seven U.S. states (Colorado, Illinois, Indiana, Kentucky, Michigan, North Carolina, and Texas) and internationally to Cyprus, Spain, and Hong Kong.
Healthcare facilities using Cobas Liat analyzer units should verify the serial numbers of their equipment against Roche's list of affected units. Facilities with affected units should contact Roche Molecular Systems, Inc. for guidance on equipment validation, replacement, or remediation options.
The recalled product
- Product
- cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
- Manufacturer
- Roche Molecular Systems, Inc.
- Category
- Medical Device
- Hazard
- false-positive
- detector-malfunction
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 (15)
- UDI: 07613336100097
- Serial Numbers: 16333
- 16454
- 16688
- 16695
- 16871
- 16914
- 17048
- 17266
- 19924
- 18094
- 18323
- 18357
- 17116
- 17086
Distribution
Distributed nationwide across the United States.
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