Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Recalled by Roche Diagnostics Corporation Due to Using the following versions of cobas infinity software...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Roche Diagnostics Corporation directly.
Affected Products
Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
Quantity: 15 units
Why Was This Recalled?
Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality control (QC) alarm when one should be present. If the QC is out of range on the stand-by bottle and it is not removed from the system, there is a potential that when the status of the Standby bottle changes from the Standby bottle to the Current bottle status, QC alarms will not be displayed next to the sample result.
Where Was This Sold?
This product was distributed to 11 states: AL, AZ, CA, GA, IA, MO, NJ, NY, SC, TN, TX
About Roche Diagnostics Corporation
Roche Diagnostics Corporation has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report