Covidien has announced that its Mallinckrodt Inc. subsidiary 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 volume or mass, the study of red blood cell survival time and evaluation of blood loss. Increased red blood cell volume is associated with a disease known as Polycythemia rubra vera, which is diagnosed by relying on various blood and other test results. Using subpotent product could lead to an incorrect result in red blood cell volume or mass. A misdiagnosis or delayed diagnosis followed by a delay in treatment puts patients at an increased risk of embolus or stroke. This recall is being conducted to inform healthcare providers of the potential for a false low reading of red blood cell volume and to prevent further use of the product. 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 U.S., Canada and Mexico. To date, the Company has accounted for 81 of the 96 vials. No adverse events or complaints have been reported with this product and this is a very small product line for Covidien.
