China NMPA Product Recall - INRatio 2 PT Monitoring System, Prothrombin Time Test Strips (Impotency Method) Alere INRatio PT/INR Test Strips

Alere (China) Medical Devices Co., Ltd. initiated a Class I voluntary recall for its INRatio 2 PT Monitoring System coagulation analyzers and Alere INRatio PT/INR Test Strips. This action was reported to the National Medical Products Administration (NMPA) on September 28, 2016, and publicly announced on December 7, 2016. The core issue was that the devices produced International Normalized Ratio (INR) results significantly lower than those from standard laboratory systems. This critical inaccuracy risked leaving patients with INR levels above the therapeutic range, consequently increasing their susceptibility to bleeding. The deficiency was first identified by Alere San Diego, Inc. in the United States following customer feedback; however, no specific complaints were received in China, where the products ceased sales in December 2014, with test strips expiring by November 2015.

Under the NMPA's regulatory guidance, Alere (China) was required to undertake several corrective measures. These included distributing an "Emergency On-Site Safety Notice" to all distributors and users. This notice advised customers to switch to alternative PT/INR testing methods without delay and provided clear instructions for managing or returning the affected analyzers and test strips. Additionally, Alere was instructed to meticulously inspect, isolate, and destroy all current inventory and returned units of the faulty products. Alere had also proactively decided to discontinue global production and market supply of the INRatio coagulation analysis system.