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

Ausendo Medical Devices Trading (China) Co., Ltd., in collaboration with manufacturer Ortho-Clinical Diagnostics, Inc., initiated a voluntary Level 1 recall concerning their "Calcium Assay Dry Tablets (Colorimetric Method)." The recall, reported on February 20, 2017, and published by the National Medical Products Administration (NMPA) on April 6, 2017, was prompted by an incorrect labeling issue.

Specifically, products from batch number 033705385108 were found to be incorrectly labeled with Chinese tags for "Alanine Aminotransferase Assay Dry Tablets (Rate Method)." A total of 2083 boxes were imported into China, with 174 boxes already distributed to hospitals and 499 boxes identified with incorrect labeling in distributor inventory. Crucially, the product's quality and functionality remained unaffected, as diagnostic machines identify the product via the original manufacturer's barcode, bypassing the erroneous Chinese label.

Under the NMPA's regulatory oversight for medical devices, Ausendo undertook comprehensive corrective actions. This involved informing distributors to rework labels on existing inventory, prohibiting sales until correction, and notifying hospital customers. Affected products sent to hospitals were replaced to ensure patient safety and regulatory compliance.