Roche Cobas infinity Software Recall for Missing Quality Control Alarms
Roche Diagnostics is recalling 15 units of Cobas infinity software versions 2.0 through 2.5 because quality control alarms may fail to display after a bottle change.
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (clinical diagnostic software) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Roche Diagnostics Corporation is recalling 15 units of the Cobas infinity central lab IT solution, specifically the Calculator/Data Processing Module (Material Number 07154003001). The affected software versions are 2.0 through 2.5. The units were distributed to laboratories in Alabama, Arizona, California, Georgia, Iowa, Missouri, New Jersey, New York, South Carolina, Tennessee, and Texas.
The recall is due to a potential software defect where quality control (QC) alarms may not display when they should. This issue can occur when using the Standby bottle function, specifically for the first sample processed after a bottle change. If the QC is out of range on the standby bottle and it is not removed from the system, the QC alarms may fail to appear next to the sample result once the bottle status changes from Standby to Current.
No specific instructions for consumers are provided in the source text, as this is a medical device software recall affecting clinical laboratories. Affected serial numbers include 81191, 81371, 81385, 81465, 81469, 81470, 81481, 81485, 81527, 81528, 81618, 81628, 81652, 81655, and 81662.
The recalled product
- Product
- Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
- Manufacturer
- Roche Diagnostics Corporation
- Affected units
- 15
Distribution
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