INR试纸因结果失准而被召回

美艾利尔集团（Alere）生产的专业国际标准化比值（INR）试纸被召回，原因是有报告称其结果“不准确性偏低”，包括几例与出血相关的死亡病例。

据该公司在美国食品药品管理局（FDA）网站上发表的声明，此次召回适用于“美艾利尔INRatio2 PT/INR专业试纸（PN 99008G2）”。该公司称，有患者投诉应用该试纸检测的INR处于治疗或接近治疗范围，但中心实验室检测结果明显较高，超出治疗范围。

声明称：“导致这一问题的根本原因尚不明确，因此，美艾利尔不能确定可能导致这一差异的患者状况。”该公司正在告知患者相关问题，并建议立即停止使用这些产品，“用其他替代方法进行PT/INR检测，如可替代美艾利尔产品的实验室血浆INR检测，或应用其他制造商的即时监测系统。”声明指出，美艾利尔收到9例与该试纸有关的严重不良事件报告，包括3例致命性出血病例。在这9例病例中，该试纸检测结果比实验室血浆INR检测结果低3.1~12.2 INR单位，具有显著差异。

该公司还要求消费者将未使用的产品寄回公司。

此次召回不包括患者家庭用美艾利尔INRatio PT/INR试纸（PN 100071）。美艾利尔主动发起此次召回。

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By: ELIZABETH MECHCATIE, Cardiology News Digital Network

Professional international normalized ratio test strips manufactured by Alere are being recalled because of reports of "inaccurately low" results, including several cases of bleeding-related fatalities.

The recall applies to the "Alere INRatio2 PT/INR Professional Test Strips (PN 99008G2)," according to a company statement posted on the Food and Drug Administration’s website. The company says there have been complaints of patients with an INR in the therapeutic or near-therapeutic range with the test strip, but whose INR was significantly higher, falling outside the therapeutic range, when tested by a central laboratory.

Alere has received nine serious adverse event reports for the test strips, which included three fatal cases of bleeding. In the nine cases, the results with the Alere INRatio2 PT/INR Professional Test Strips were 3.1-12.2 INR units lower than the laboratory plasma INR test results – a significant difference, according to the statement.

"The root cause for this issue has not yet been determined; therefore Alere cannot determine the patient conditions or circumstances that may contribute to the discrepancy," the statement said. The company is advising customers about the problem and to immediately stop using these products "and use an alternative method to perform PT/INR testing, such as a plasma-based laboratory INR test, an alternative Alere product, or an alternative point-of-care monitoring system from a different manufacturer."

The company is also requesting that customers send unused product back to the company.

The recall does not apply to AlereINRatio PT/INR Test Strips (PN 100071), used by patients at home. The recall was voluntary, initiated by Alere.