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FDAApril 8, 2019device

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 V...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

10758750004409

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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