Roche cobas z 480 Analyzer Recalled for Dirty Lens Risk
Roche is recalling cobas z 480 analyzers because a dirty lens may cause invalid or false positive results.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (invalid or false positive diagnostic results) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Roche Molecular Systems, Inc. is recalling the cobas z 480 analyzer, a plate-based automated amplification and detection system for nucleic acids. The recall is due to a dirty lens that may cause invalid or false positive results.
The affected units are intended to be used as an in-vitro diagnostic or screening system providing real-time PCR amplification and detection for human samples. The product is used by laboratory professionals trained in laboratory techniques. The recall covers 597 units in the United States and 3,411 units outside the United States.
The recall is classified as Class II by the FDA. Users should contact Roche Molecular Systems, Inc. for further instructions on how to proceed with the affected equipment.
The recalled product
- Product
- The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as an in-vitro diagnostic or screening system providing real time PCR amplification and…
- 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 units UDI: 04015630929016
Distribution
Distributed nationwide across the United States.
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
- ModerateCobas Liat respiratory virus analyzer units recalled for false Influenza B results
FDA (Devices) · 2022-04-06
Same hazard · false positive results
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- HighQuickVue Dipstick Strep A Test Recalled for False Positive Results
FDA (Devices) · 2026-05-20
- ModerateLeadCare II Blood Lead Test Kit Recall for Inaccurate Results
FDA (Devices) · 2026-04-29
- ModerateLeadCare Ultra Blood Lead Test Kit Recalled for False Positive Results
FDA (Devices) · 2026-04-29
- HighLeadCare Plus Blood Lead Test Kit Recalled for Unexpectedly Elevated Results
FDA (Devices) · 2026-04-29
Similar recalls
- ModerateRoche Recalls COBAS INTEGRA 400 Analyzer Software Due to Diagnostic Issue
FDA (Devices) · 2012-12-19
- SevereRoche cobas Liat Analyzer Respiratory Virus Panel Recall
FDA (Devices) · 2021-04-21
- ModerateRoche cobas 6000 Analyzer Filters Recalled for Potential Aspiration Issues
FDA (Devices) · 2014-06-25
- SevereRoche COBAS INTEGRA 800 Analyzer Recalled Due to Sharp Edge Injury Reports
FDA (Devices) · 2016-11-02
- ModerateRoche cobas 8000 Analyzer Filters Recalled for Potential Performance Issues
FDA (Devices) · 2014-06-25
- HighRoche Cobas Infinity Software Error May Allow Unreliable Lab Results
FDA (Devices) · 2021-01-27