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

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/962b5d36-97a8-459e-b801-a8ba58a247e6/
Source feed: China

> China NMPA product recall for Calcium determination using dry slides (colorimetric method) by Ortho-Clinical Diagnostics, Inc. published March 17, 2017. Recall level: . Ausendo Medical Devices Trading (China) Co., Ltd., collaborating with manufacturer Ortho-Clinical Di

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling its calcium assay dry tablets (colorimetric method).
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2017-03-17
- Product Name: Calcium determination using dry slides (colorimetric method)
- Recall Reason: Some of the calcium assay dry tablets (colorimetric method) of this batch in China were incorrectly labeled with Chinese labels indicating alanine aminotransferase assay dry tablets.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/ortho-clinical-diagnostics-inc/1aeceeb0-508e-4f89-ae53-22ef3ba7bd86/