Ortho Clinical Diagnostics Inc recalls 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values excee…

Recall date

October 14, 2019

Source

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

Recall number

Z-0739-2020

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

7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.