Roche COBAS 8000 Analyzer Software Recall for Diagnostic Issue
Roche Molecular Systems is recalling 77 COBAS 8000 modular analyzers nationwide due to a device-associated diagnostic software issue.
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: The recall is classified as FDA Class II. The source text does not report any illnesses, injuries, or deaths, and the hazard is described generally as a software issue without specific injury reports, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Roche Molecular Systems, Inc. is recalling 77 units of the COBAS 8000 data manager modular analyzer series. The recall covers all versions of this fully automated, random-access, software-controlled system used for immunoassay and photometric analysis. The devices are intended for qualitative and quantitative in-vitro determinations.
The recall is being conducted because the manufacturer became aware of a device-associated diagnostic software issue. The source text does not specify the exact nature of the software defect or the potential impact on test results. No illnesses, injuries, or deaths are reported in the provided text.
The affected units were distributed nationwide. The source text does not provide specific instructions for consumers or healthcare providers on how to proceed, such as contacting the manufacturer or stopping use of the device.
The recalled product
- Product
- The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.
- Manufacturer
- Roche Molecular Systems, Inc.
- Hazard
- Affected units
- 77
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)
- Device-associated diagnostic software
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 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.
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