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Roche Diagnostics Operations, Inc. recalls cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
Recalled February 19, 2020 · FDA recall Z-1158-2020 · Roche Diagnostics Operations
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. · FDA Class II
Units
26 accounts
Sold at
Distributed to customers in AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, and TN.
Description
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.
Product
cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →