China NMPA Product Recall - Chloride ion determination dry film (direct electrode method); Potassium ion determination dry film (direct electrode method)

Ortho-Clinical Diagnostics, Inc. initiated a voluntary Class II recall for its Chloride Ion Determination Dry Tablets (Direct Electrode Method) and Potassium Ion Determination Dry Tablets (Direct Electrode Method). This action, reported on September 20, 2019, by the Shanghai Food and Drug Administration under the oversight of the National Medical Products Administration (NMPA), addresses intermittent dry tablet distribution issues. The problem stems from the magazine mechanism in some product batches, potentially affecting the accuracy and reliability of diagnostic tests. A Class II recall indicates that product use may lead to temporary or medically reversible adverse health consequences, or where serious adverse health consequences are remote. Ortho-Clinical Diagnostics, Inc. undertook this measure to ensure product quality and uphold patient safety. Specific details regarding affected product models, specifications, and batches are provided in an associated Medical Device Recall Event Report Form. This voluntary recall demonstrates the company's commitment to maintaining high standards for medical device performance and regulatory adherence.