Abbott Initiates Class III Recall of ARCHITECT EBV VCA IgM Calibrator Due to Potential RLU Signal Reduction

Economic Daily-China Economic Net, Beijing, November 25 — On November 23, the National Medical Products Administration announced the report on the voluntary recall by Abbott Trading (Shanghai) Co., Ltd. of its ARCHITECT EBV VCA IgM Calibrator product for Epstein-Barr virus viral capsid antigen IgM antibody calibration. The recall is classified as Class III.

Abbott Trading (Shanghai) Co., Ltd. reported that, due to potentially reduced RLU signals in specific models and batches of products, the cutoff RLU value during assay calibration may decrease, leading to an upward drift in the quality control S/CO values. In the S/CO range of 0.50–0.56, non-reactive results may be falsely reported as indeterminate for patients; in the S/CO range of 1.00–1.13, indeterminate results may be falsely reported as reactive for patients.

It is understood that the recalled product is intended for calibrating Epstein-Barr virus (EBV) viral capsid antigen (VCA) IgM antibodies during the in vitro qualitative determination of EBV VCA IgM antibodies in human serum and plasma.

The report indicates that the affected products were not exported to China.