Covidien’ subsidiary, Mallinckrodt is voluntarily recalling one lot of Mallinckrodt Sodium Chromate Cr-51 Injection (lot #370-9004), as a result of routine post-market testing in which the product was found to be subpotent.
Sodium Chromate Cr-51 Injection is a radiopharmaceutical diagnostic agent used in the determination of red blood cell (RBC) volume or mass, study of red blood cell survival time, and evaluation of blood loss.
Using subpotent product could lead to an incorrect result in red blood cell volume or mass. This recall is being conducted to inform healthcare providers of the potential for a false low reading of RBC volume and to prevent further use of the product, said the company.
Covidien decided to recall lot #370-9004, consisting of 96 distributed vials, on June 23, 2009, and has been in the process of recovering those vials from customers in the US, Canada and Mexico.