Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
This recall has been terminated (originally issued October 8, 2019).
- Recall Initiated
- October 8, 2019
- Terminated
- October 15, 2020
- Recall Number
- Z-0922-2020
- Quantity
- 20
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping
Distribution
US Nationwide in the states of AL, CA, GA, IA, IL, KY, MI, MO, MT, NJ, NY, OR, TN
Lot / Code Info
Cobas infinity software version 2.4.1 through 2.5.4
Root Cause
Software design
Action Taken
Roche issued Urgent Medical Device Correction TP-00791 mailed via UPS Ground (receipt required) on 10/8/2019. The letter identifies the problem, health risk and action to take: Complete the attached fax form (TP-00792) and fax or email it according to the instructions on the form. " File this Urgent Medical Device Correction (UMDC) for future reference Roche will resolve this issue in a future software update. In the next couple of weeks, a Roche Representative will be contacting you to adjust alarm code mapping as needed per your specific configuration. Contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-526-2272 if you have questions. The UMDC will also post to the diagnostics.roche.com website