ST LOUIS (MD Consult) - On July 9, 2009, the US Food and Drug Administration announced that Covidien's subsidiary Mallinckrodt Inc is voluntarily recalling 1 lot of Sodium Chromate Cr-51 injection (lot #370-9004) after routine postmarket testing revealed that the product was 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. Using a subpotent product for testing in patients with this condition could lead to an incorrect interpretation of red blood cell volume or mass. This, in turn, could lead to a misdiagnosis or delayed diagnosis followed by a delay in treatment that may place patients at an increased risk of embolus or stroke. This recall is being conducted to inform health care providers of the potential for a false low reading of red blood cell volume in tested patients 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 United States, Canada, and Mexico. To date, the company has accounted for 81 (84%) of the 96 vials. No adverse events or complaints have been reported with this product.

圣路易斯(MD Consult)——本月9日，美国食品药品管理局宣布，在常规上市后检测发现产品出现减效后，柯惠的子公司万灵科正自愿召回一批铬酸钠Cr-51 (批号：370-9004)。铬酸钠Cr-51注射液为一种放射药物诊断剂，临床上用于定量红细胞容积或质量，研究红细胞生存时间和评估失血情况。

红细胞容积增加与真性红细胞增多症相关。运用减效的试剂来检测真性红细胞增多症患者时，经常导致红细胞容积或质量的错误解析。这样随后的后果是诊断错误或延误，从而延误治疗，患者出现血栓或中风的几率增大。该召回意在提醒医疗人员测试患者中可能出现红细胞容积的假低读数现象，也是防止减效产品的继续使用。

柯惠于今年6月23日决定召回批号为370-9004共96小瓶的产品。该公司正从美国、加拿大和墨西哥的客户手中召回这些药瓶。至今，81瓶(84%)已经确认下落。该产品尚无任何不良反应或投诉的报道。