medical Class II Updated 2020-02-19

Roche Diagnostics Operations, Inc. recalls cobas infinity core, Material No. 7154003001. The device is

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, TN

Lot/Code Info: All cobas infinity laboratory solution software versions are affected.

View official government recall

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