—#179073

Product

cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: All cobas infinity laboratory solution software versions are affected.

Why it was recalled

Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On 1/7/2020, the firm distributed Urgent Medical Device Correction letters to affected consignees. Customers were asked to do the following: " Be aware of the incorrect display of the alarm flags on the cobas infinity Validation screen if an alarm has a < symbol in front of it and if doing manual validations. " It is not recommended to use the alarm mapping function on the cobas infinity until your system is patched. If your laboratory does use it, please call the Roche Support Network Customer Support Center at 1-800-526-2272 for further information. " Complete the customer response form and return it to the recalling firm. Please 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 about the information contained in this UMDC.

Recalling firm

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

Distribution

Distribution pattern: Distributed to customers in AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, and TN.

Timeline

Recall initiated: 2020-01-07
Terminated: 2020-10-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179073. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.