Roche Cobas Infinity Software Error May Allow Unreliable Lab Results
Roche is recalling 76 licenses of Cobas Infinity software due to an error that may remove quality flags, allowing unreliable test results to be reported.
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 involves a risk-of-harm product (medical device software) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 76 licenses of the Cobas Infinity calculator/data processing module, catalog number 07154003001. The recall covers all versions from 3.00.00 onwards distributed nationwide in the United States.
The recall is due to a software error that can unintentionally remove the serum-indices flag. This flag is normally used to hold results for manual review when sample quality issues, such as hemolysis, icterus, or lipemia, are detected. The error may allow samples of poor quality to return unreliable or incorrect test results that are reported to health care providers or patients without the proper disclaimer regarding sample quality.
Health care providers and laboratories using the affected software should contact Roche for instructions on how to address the software error and ensure proper review of test results.
The recalled product
- Product
- A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 76
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 versions from cobas infinity version 3.00.00 onwards
Distribution
Distributed nationwide across the United States.
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