China NMPA Product Recall - Fully automated blood typing analyzer

On September 16, 2020, Ortho Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class II recall for its fully automated blood typing analyzers. This action, overseen by the National Medical Products Administration (NMPA) of China, addresses a significant performance issue related to specific system reagent cards. The main concern arises from the potential for inconsistent positive results during indirect antiglobulin assay (IAT) crossmatch testing. Specifically, when using Anti-Human Globulin Anti-IgG, -C3d; multispecific Ortho BioVue system reagent cards (product numbers 707300/707350) with the ORTHO VISION and ORTHO VISION Max systems, the devices may intermittently produce unreliable positive outcomes. This issue is particularly noted in samples from healthy donors and patients exhibiting high antibody titers (exceeding 10²⁴). Consequently, Ortho-Clinical Diagnostics (UK) Ltd., the manufacturer, has commenced a voluntary recall of affected blood typing analyzer models, identified by Registration Certificate Nos.: 20173402355 and 20173402376. Detailed information regarding specific product models, specifications, and batch numbers is available in the accompanying "Medical Device Recall Event Report Form" to ensure the integrity and reliability of critical blood compatibility testing.