Roche Recalls cobas infinity core Software Due to Display Error
Roche Diagnostics is recalling cobas infinity core software modules because alarm flags with a '<' symbol are not displayed on the Validation screen.
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 hazard involves a software display error that may prevent users from seeing specific alarm flags, representing a risk of harm without reported injuries or fatalities, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling the cobas infinity core, Material No. 7154003001. This device is a calculator and data processing module intended for clinical use. The recall affects 26 accounts and all cobas infinity laboratory solution software versions.
The recall was initiated because alarm flags containing a '<' symbol are not displayed on the cobas infinity Validation screen. This issue specifically affects customers who perform manual validation on the Validation screen.
The affected products were distributed to customers in Alaska, Alabama, California, Georgia, Hawaii, Iowa, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, New Jersey, New York, Oregon, South Carolina, and Tennessee. Users should contact Roche Diagnostics for further instructions regarding the software update or replacement.
The recalled product
- Product
- cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 26
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 cobas infinity laboratory solution software versions are affected.
Distribution
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