—#177289

Product

Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Cobas infinity software version 2.4.1 through 2.5.4

Why it was recalled

Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping

Root cause (FDA determination)

Software design

Action the firm took

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

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: US Nationwide in the states of AL, CA, GA, IA, IL, KY, MI, MO, MT, NJ, NY, OR, TN

Timeline

Recall initiated: 2019-10-08
Terminated: 2020-10-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177289. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.