China NMPA Product Recall - Bcl-6 antibody reagent (immunohistochemistry) Bond Ready-to-Use Primary Antibody Bcl-6 (LN22)

Leica Biosystems Newcastle Ltd has initiated a voluntary Class III recall of its Bcl-6 antibody reagent, specifically the Bond Ready-to-Use Primary Antibody Bcl-6 (LN22). This action, reported by Leica Microsystems (Shanghai) Trading Co., Ltd. and published by the National Medical Products Administration (NMPA) on December 16, 2022, addresses critical quality control issues. The primary reasons for the recall include errors in the allocation of batch numbers and expiration dates for specific product models and batches. Furthermore, investigations revealed that the actual concentration of the antibody reagent was lower than the concentration indicated on the product label. These discrepancies highlight a failure in maintaining accurate product labeling and consistent manufacturing quality, which could compromise the reliability of the immunohistochemistry reagent in diagnostic applications. A Class III recall indicates that the product defects are unlikely to cause adverse health consequences, but the company is taking corrective measures to address these non-conformities and uphold product integrity, aligning with regulatory standards for medical device quality and safety.