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Ortho Clinical Diagnostics Inc recalls 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed
Recalled January 1, 2020 · FDA recall Z-0739-2020 · Ortho Clinical Diagnostics
Hazard
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 · FDA Class II
Units
16,584
Sold at
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.
Description
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
Product
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.
Manufacturer(s)
Ortho Clinical Diagnostics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →