China NMPA Product Recall - Quality control products for fully automated biochemical analyzers

Ortho Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class III recall of specific quality control products for fully automated biochemical analyzers, as reported by the National Medical Products Administration (NMPA) on August 31, 2020. The recall stemmed from an identified error in the mean range (ROM) of quality control products from batches M7697/N7698. This particular issue affected the accurate determination of cerebrospinal fluid samples when analyzed using certain generations of glucose assay dry tablets (colorimetric method). The company confirmed that this error was isolated to the specified batch and application, assuring that other quality control product batches, VITROS test kits, generations, or body fluids remained unaffected. Crucially, the company emphasized that patient results were not compromised by this discrepancy. The regulatory oversight for this action falls under the NMPA, with the announcement sourced from the Shanghai Municipal Drug Administration Website. The required action by Ortho Medical Devices Trading (China) Co., Ltd. was the voluntary recall of the affected quality control materials, identified by Registration Certificate No.: 20152402824, to address the identified product deviation.