China NMPA Product Recall - Myoglobin assay kit (immunoturbidimetric method)

Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Level II recall of a specific batch of its Myoglobin Assay Kit (Immunoturbidimetric Assay) on July 16, 2019. This action followed a complaint investigation by Roche Diagnostics headquarters, which identified performance issues with batch number 34986001 of the assay kit. The identified problem involved occasional poor repeatability of quality control results and calibration failures when the kit was utilized on the cobas c 311/501/502 analytical platforms. This deficiency could potentially impact the accuracy and reliability of diagnostic test results. The recall is being conducted under the oversight of China's National Medical Products Administration (NMPA) and references registration details from the Shanghai Food and Drug Administration. A Level II recall indicates that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Roche Diagnostics Products (Shanghai) Co., Ltd. has taken the necessary step to remove the affected product from the market to mitigate potential risks to patient safety and ensure diagnostic integrity. Further details regarding specific models and quantities are documented in the "Medical Device Recall Event Report Form" associated with this announcement.