China NMPA Product Recall - Anti-human globulin (IgG, C3b/C3d) test card

Ortho Medical Devices Trading (China) Co., Ltd. initiated a voluntary Class III recall of its anti-human globulin (IgG, C3b/C3d) test cards. This recall was reported to the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, as detailed in a December 18, 2020, publication. The primary issue stemmed from customer reports indicating incorrect results (0.5+ or Indeterminate) when the test cards were used with ORTHO VISION, ORTHO VISION Max, and Ortho AutoVue fully automated blood typing analyzers. These erroneous readings occurred with both patient and quality control samples, where a negative result was anticipated. The company proactively reported the incident and is executing the recall to address the product's performance discrepancy. Further specific details regarding affected product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form" referenced in the official announcement.