Ortho-Clinical Diagnostics recalls VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584)…

Recall date

July 11, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3193-2018

FDA classification

Class III

Brand / firm

Ortho-Clinical Diagnostics

Sold / distributed

Worldwide distribution. US nationwide, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and United Kingdom.

Why it was recalled

The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for serum and urine samples and therefore affecting the low end of the measuring range for this assay. The current low end measuring range is 0.05mg/dL for serum and 1.2mg/dL for urine. Based on the CREA testing results for the LoQ, the revised low end CREA measuring range is 0.15mg/dL for serum and 3.2mg/dL for urine.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.