Roche Diagnostics Operations, Inc. recalls Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material…
- Recall date
- October 8, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0922-2020
- FDA classification
- Class II
- Brand / firm
- Roche Diagnostics Operations, Inc.
- Sold / distributed
- US Nationwide in the states of AL, CA, GA, IA, IL, KY, MI, MO, MT, NJ, NY, OR, TN
Why it was recalled
Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping
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 central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
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