Roche Cobas 8000 Modular Series Software Recall for Incorrect Results Risk
Roche Diagnostics is recalling 399 Cobas 8000 Modular Series systems due to a software failure that may reset settings to defaults, creating a risk of incorrect test results.
What this means for you
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 where a software failure creates a risk of incorrect results, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Roche Diagnostics Corporation is recalling 399 units of the Cobas 8000 Modular Series system, specifically those running Software Version 05-02 and 06-03. The recall is due to a software failure that may incorrectly set the system settings to "default" settings. This malfunction creates a risk of incorrect results from the diagnostic equipment.
The affected units were distributed in 36 states: AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, and Puerto Rico. The recall covers specific serial numbers listed in the official FDA record Z-0675-2018.
Healthcare facilities and users should check their system software versions and serial numbers against the recall list. If the equipment is affected, users should contact Roche Diagnostics Corporation for instructions on how to resolve the software issue to prevent incorrect diagnostic results.
The recalled product
- Product
- Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
- Manufacturer
- Roche Diagnostics Corporation
- Affected units
- 399
Distribution
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