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

The National Medical Products Administration (NMPA) oversaw a Class II voluntary recall initiated by Aussendo Medical Devices Trading (China) Co., Ltd., concerning specific batches of Calcium Assay Dry Tablets (Colorimetric Method) manufactured by Ortho-Clinical Diagnostics, Inc. The recall, reported on August 29, 2016, stemmed from the discovery that Generation 29 of these diagnostic tablets produced biased or deviation results when utilized for plasma or serum testing. This issue compromised the accurate quantitative determination of calcium content in blood samples, although urine sample results were not indicated as being affected. The regulatory framework for this recall falls under NMPA guidelines, highlighting a commitment to patient safety and product reliability in medical diagnostics.

The affected products, registered under certificate number 20152402836, included multiple batch numbers such as 2905288192, 2905288323, 2905288360, and 2905288361, and had global distribution, including specific quantities sold in China. As immediate corrective actions, customers were instructed to cease using and discard all remaining stock of the problematic Vitros Calcium Dry Tablets (Generation 29). Ortho-Clinical Diagnostics Trading (China) Co., Ltd., the responsible unit, committed to providing compliant substitute products to affected customers, and all unused, recalled product stock was slated for destruction.