Ortho Clinical Diagnostics Inc recalls Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium…

Recall date

October 14, 2019

Source

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

Recall number

Z-0740-2020

FDA classification

Class II

Brand / firm

Ortho Clinical Diagnostics Inc

Sold / distributed

Worldwide distribution - US Nationwide distribution and countries BM, AU, BR, CA, CL, CN, CO, IN, JP, MX, SG, GB, FR, DE, IT, ES, PT, PL, RU, DK, NO, SE, BE, NL.

Why it was recalled

Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days.

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

What was recalled

Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.