Ortho-Clinical Diagnostics recalls VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and quali…
- Recall date
- October 19, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0650-2019
- FDA classification
- Class II
- Brand / firm
- Ortho-Clinical Diagnostics
- Sold / distributed
- US Nationwide Distribution
Why it was recalled
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
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 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
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