China NMPA Product Recall - Red blood cell reagent for irregular antibody screening

On October 11, 2017, Bio-Rad Biomedical Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Red Blood Cell Reagent for Irregular Antibody Screening. This action was prompted by the company's report that certain batches of the product, registered under No. 20153402292, may exhibit unexpected positive reactions. Such reactions could potentially lead to inaccurate diagnostic outcomes, impacting patient care. The recall was conducted under the regulatory framework of the National Medical Products Administration (NMPA). A Class III recall indicates that while the product's use is not likely to cause adverse health consequences, it is still deemed non-compliant and requires removal from distribution. Detailed information concerning the specific models, specifications, and affected batch numbers of the recalled product is contained within the 'Medical Device Recall Event Report Form' submitted by Bio-Rad Biomedical Products (Shanghai) Co., Ltd. to the NMPA, outlining the company's required actions to address this quality issue.