Ortho-Clinical Diagnostics recalls VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product Usage: Performs discrete clinical t…
- Recall date
- April 8, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1934-2019
- FDA classification
- Class II
- Brand / firm
- Ortho-Clinical Diagnostics
- Sold / distributed
- US Nationwide Distribution
Why it was recalled
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
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 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.
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