Ortho-Clinical Diagnostics recalls VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quanti…

Recall date

January 22, 2019

Source

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

Recall number

Z-0992-2019

FDA classification

Class II

Brand / firm

Ortho-Clinical Diagnostics

Sold / distributed

US Distribution to states of: AL, CA, CT, FL, HI, IA, ID, IL, LA, MI, MO, MS, NC, NM, NY, OK, PA, TX, WV, and WY; and internationally to: Canada.

Why it was recalled

Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.

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 Chemistry Products Na+ Slides, Catalog Number 8379034 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.