China NMPA Product Recall - Fully automated blood typing analyzer (ORTHO VISION v® Analyzer, VISION® Max Analyzer)

Ortho-Clinical Diagnostics (UK) Ltd. initiated a voluntary Class II recall of its fully automated blood typing analyzers, specifically the ORTHO VISION v R Analyzer (Registration Certificate 20173222376) and VISION R Max. Analyzer (Registration Certificate No. 20173222355). This recall, announced on November 17, 2023, was prompted by the potential for reagent antibody contamination in specific tests. This contamination could lead to intermittent false positive results, posing a risk to accurate blood typing. The regulatory oversight for this action falls under the National Medical Products Administration (NMPA) of China, as indicated by the official publication and medical device registration certificates. A Class II recall signifies that the product may cause temporary or reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. As a required action, Ortho-Clinical Diagnostics (UK) Ltd. is facilitating the recall, and comprehensive details regarding the specific affected product models, specifications, and batches are documented in the "Medical Device Recall Event Report Form." This proactive measure aims to mitigate potential patient risks associated with inaccurate blood typing results and ensure compliance with medical device safety standards.