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

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/cb15e36b-a179-4768-b9a8-dffd2557723b/
Source feed: China

> China NMPA product recall for Calcium determination using dry slides (colorimetric method) by Ortho-Clinical Diagnostics, Inc. published April 06, 2017. Recall level: . Ausendo Medical Devices Trading (China) Co., Ltd., in collaboration with manufacturer Ortho-Clinical

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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: 2017-04-06
- Product Name: Calcium determination using dry slides (colorimetric method)
- Recall Reason: Some products of this batch of calcium assay dry tablets (colorimetric method) in China were incorrectly labeled with Chinese tags indicating they were for alanine aminotransferase assay dry tablets (rate method). During machine operation, because the machine reads the original manufacturer's barcode for product identification and does not involve the Chinese label, it still identifies the product as calcium assay dry tablets (colorimetric method) and performs subsequent tests for calcium assay dry tablets (colorimetric method) under user operation, without performing the alanine aminotransferase assay dry tablets (rate method) test. The product quality itself is not affected, and Ausendo has initiated corrective action based on regulatory compliance.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: 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.

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