Ortho-Clinical Diagnostics: Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.

Agency Publication Date: July 3, 2019

Affected Products

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.

All lots

Product: 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.

All lots

Product: VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) 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.

All lots

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.

All lots

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 82784

Status: Resolved

Manufacturer: Ortho-Clinical Diagnostics

Manufactured In: United States

Units Affected: 4 products (5020 units; 57 units; 2411 units; 3889 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

All lots