Roche Diagnostics Operations, Inc. recalls cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
- Recall date
- July 18, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2476-2019
- FDA classification
- Class II
- Brand / firm
- Roche Diagnostics Operations, Inc.
- Sold / distributed
- State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK
Why it was recalled
Quality issue with high pressure solenoid valves may cause inaccurate results.
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 e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
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