China NMPA Product Recall - Calcium determination using dry slides (colorimetric method)

Ausendo Medical Devices Trading (China) Co., Ltd., acting on behalf of manufacturer Ortho Clinice Diagnostos, initiated a Class III voluntary recall for its Calcium Assay Dry Tablets (Colorimetric Method). This recall, reported to the National Medical Products Administration (NMPA) on February 20, 2017, and publicly announced on April 17, 2017, was prompted by an incorrect labeling issue. A specific batch (033705385108) of Calcium Assay Dry Tablets, with 2030 boxes imported into China, was found to have Chinese labels for "Alanine Aminotransferase Assay Dry Tablets (Reverse Rate Method)" incorrectly applied to some units.

While the product's intrinsic quality remained unaffected and laboratory machines correctly identified the product using its original barcode, the misapplied Chinese label could potentially confuse users during manual operation, leading to incorrect test procedures for calcium determination. To address this, distributors were instructed to rework labels on existing inventory, with sales suspended until completion. Hospital customers who received affected products were promptly notified, and replacements were provided for all mislabeled units. These actions were taken to ensure regulatory compliance and prevent any user confusion stemming from the labeling discrepancy.