Roche Diagnostics Operations, Inc. recalls cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
- Recall date
- January 7, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1158-2020
- FDA classification
- Class II
- Brand / firm
- Roche Diagnostics Operations, Inc.
- Sold / distributed
- Distributed to customers in AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, and TN.
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
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