China NMPA Product Recall - Glycated hemoglobin assay kit (immunoturbidimetric method)

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Glycated Hemoglobin Detection Kit (Immunoturbidimetric Assay), registered under CFDA (Imported) 2014 No. 2403078. The recall, reported on June 19, 2017, was prompted by consistent findings of a high recovery rate during both internal quality control assessments and patient sample testing. This issue indicated a potential inaccuracy in the diagnostic kit's performance, which could affect the reliability of hemoglobin A1c measurements critical for diabetes management. The National Medical Products Administration (NMPA) was informed of this action. While specific inspection dates are not detailed, the company's proactive measure underscores its commitment to product quality and patient safety within the regulatory framework governing medical devices. The recall ensures that potentially compromised batches of the diagnostic kit are removed from circulation, mitigating risks associated with inaccurate diagnostic results.