Ortho Clinical Diagnostics recalls VITROS 250 Chemistry System, clinical chemistry analyzer
- Recall date
- July 8, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2175-2019
- FDA classification
- Class II
- Brand / firm
- Ortho Clinical Diagnostics
- Sold / distributed
- Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
Why it was recalled
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
VITROS 250 Chemistry System, clinical chemistry analyzer
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