Ortho-Clinical Diagnostics recalls VITROS 350 Chemistry System, Product Code 6802153, (UDI #
Recalled Product
VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) 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.
Hazard / Issue
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
Issued by
FDA
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