Ortho-Clinical Diagnostics recalls VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodi…

Recall date

December 20, 2016

Source

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

Recall number

Z-1117-2017

FDA classification

Class II

Brand / firm

Ortho-Clinical Diagnostics

Sold / distributed

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.

Why it was recalled

There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ Slide cartridges warmed at room temperature and loaded onto the analyzer after using the minimum warm up requirements stated in the IFU. If Quality Control (QC) results are within acceptable limits, reported results are acceptable and were not affected by this issue.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.