medical Class II Updated 2019-07-10

Ortho-Clinical Diagnostics recalls VITROS 250 Chemistry System Refurbished, Product Code 680175

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lots
View official government recall

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