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Ortho-Clinical Diagnostics recalls VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinica
Recalled July 10, 2019 · FDA recall Z-1933-2019 · Ortho-Clinical Diagnostics
Hazard
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems. · FDA Class II
Units
5020 units
Sold at
US Nationwide Distribution
Description
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
Product
VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) 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.
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →