Roche cobas infinity software may release incorrect test results to laboratories
Roche Diagnostics is recalling cobas infinity central lab software versions 3.01.03–3.02.08 because under certain circumstances, the software may automatically send false test results to laboratory information systems. Correct results remain available on the instrument.
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: FDA Class II recall of diagnostic software with potential to produce false laboratory results. This is a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion per the rubric. No illnesses or injuries have been documented.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling cobas infinity central lab software version 3.01.03 through 3.02.08, which is used in clinical laboratory diagnostic systems.
Under specific circumstances, the software may automatically replace test results with false results (false positives or negatives) and transmit them to the laboratory information system (LIS) where they could be released and interpreted as accurate. The correct result remains available on the instrument itself.
Approximately 2,058 licenses of the affected software are distributed worldwide, with 79 licenses in the United States. Laboratories should contact Roche Diagnostics for information regarding this recall.
The recalled product
- Product
- cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
- Manufacturer
- Roche Diagnostics Operations, 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 (2)
- UDI: 04015630936007
- All systems running software version 3.01.03 - 3.02.08
Distribution
Distributed nationwide across the United States.
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