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Ortho-Clinical Diagnostics recalls VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quan
Recalled March 20, 2019 · FDA recall Z-0992-2019 · Ortho-Clinical Diagnostics
Hazard
Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results. · FDA Class II
Units
1448
Sold at
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.
Description
Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.
Product
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.
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →