China NMPA Product Recall - Folic acid test kit (electrochemiluminescence immunoassay); multiple immunoassay quality control products

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall, as reported on May 18, 2020, under the National Medical Products Administration (NMPA) framework. The recall concerns specific batches of its Folic Acid Assay Kit (Electrochemiluminescence) (batch number 414367) and Immunoassay Quality Control Product (batch number 431664). The company received complaints regarding high recovery rates of quality control products when these two items were used concurrently on a Cobase 411 analyzer. A subsequent investigation by Roche Diagnostics headquarters confirmed a consistent trend of elevated quality control recovery rates, specifically noting that Quality Control Level 2 results surpassed acceptable thresholds. Despite these findings, the company affirmed that patient health and diagnostic outcomes were unaffected, concluding that associated medical risks were negligible. As a corrective measure, Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling the implicated Folic Acid Assay Kit (electrochemiluminescence immunoassay) and immunoassay multiplex quality control products. This action ensures adherence to quality standards while proactively addressing the identified deviation in product performance.