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

Ausendo Medical Devices Trading (China) Co., Ltd., collaborating with manufacturer Ortho-Clinical Diagnostics, Inc., initiated a voluntary Level 1 recall for its "Calcium Assay Dry Tablets (Colorimetric Method)" products. This action was reported on February 20, 2017, and subsequently published by the National Medical Products Administration (NMPA) on March 17, 2017. The core issue involved an incorrect Chinese label on products from Batch Number 033705385108, which erroneously identified them as "alanine aminotransferase assay dry tablets." Although the product's intrinsic quality remained unaffected and testing equipment correctly identified the product via the original manufacturer's barcode, this represented a non-compliance with NMPA labeling standards.

The recall impacted 2083 boxes imported into China, with 174 boxes already delivered to hospitals. In response, the company is undertaking several corrective actions under the NMPA framework. These include immediately informing distributors to correct the mislabeling on all existing inventory, strictly prohibiting any further sales until the labels are reworked, and notifying hospital customers about the discrepancy, offering replacements for affected products. These measures aim to ensure accurate product identification and regulatory adherence.