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.
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 2/5 (Moderate).
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
- Affected units
- 14
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
Related recalls
Same manufacturer · Roche Molecular Systems, Inc.
See all →- HighRoche cobas Influenza Test Recall Due to False Negative Results
FDA (Devices) · 2023-02-15
- HighRoche Influenza A/B and RSV Test Kit Recalled for False Negative Results
FDA (Devices) · 2023-02-15
- HighRoche cobas Flu/COVID assay recalled for false negative influenza results
FDA (Devices) · 2023-02-15
- HighMedical Device Recall: Roche cobas 5800 False Results Due to Baseline Anomalies
FDA (Devices) · 2022-10-26
- HighCobas EGFR Mutation Test v2 may return false mutation detection results
FDA (Devices) · 2021-10-20
Same hazard · false positive
See all →- ModerateBioFire FilmArray Pneumonia Panel Plus Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire Joint Infection Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- HighAlere San Diego Recalls hCG Urine Pregnancy Tests for False Positives
FDA (Devices) · 2026-10-07
- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighpTau 217 plasma calibrators recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
Similar recalls
- SevereRoche cobas Liat Analyzer Respiratory Virus Panel Recall
FDA (Devices) · 2021-04-21
- HighRoche cobas Flu/COVID assay recalled for false negative influenza results
FDA (Devices) · 2023-02-15
- HighRoche cobas Influenza Test Recall Due to False Negative Results
FDA (Devices) · 2023-02-15
- Highcobas SARS-CoV-2 and Influenza A/B Test Recalled Due to False Positive Results
FDA (Devices) · 2021-09-29
- HighRoche Recalls cobas SARS-CoV-2 and Influenza Assay Reagents
FDA (Devices) · 2021-04-21
- HighRoche Influenza A/B and RSV Test Kit Recalled for False Negative Results
FDA (Devices) · 2023-02-15