Roche Cobas infinity Software Recalled for Incorrect Alarm Mapping
Roche Diagnostics is recalling 20 Cobas infinity software modules due to incorrect alarm mapping. The software versions 2.4.1 through 2.5.4 are affected.
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 medical device with a functional defect (incorrect alarm mapping) that poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 20 units of the Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module. The affected software versions range from 2.4.1 through 2.5.4. The recall is due to incorrect alarm mapping when using a CommServer Driver.
The affected units were distributed nationwide in the states of Alabama, California, Georgia, Iowa, Illinois, Kentucky, Michigan, Missouri, Montana, New Jersey, New York, Oregon, and Tennessee. The product is intended for clinical use.
Consumers and healthcare facilities should contact Roche Diagnostics Operations, Inc. for further instructions on how to address the software defect.
The recalled product
- Product
- Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 20
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)
- Cobas infinity software version 2.4.1 through 2.5.4
Distribution
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