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FDAJanuary 7, 2020device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

roche diagnostics operationsrocheroche diagnostics

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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