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

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/d2f1b449-74b2-4a91-b5a3-815e7551b5e7/
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 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., collaborating with manufacturer Ortho-Clinical Diagnostics, Inc., initiated a voluntary Level 1 recall for its Calcium Assay Dry Tablets (Colorimetric Method) (Batch No. 033705385108). This recall was officially reported on February 20, 2017, and publicly announced by the National Medical Products Administration (NMPA) on March 17, 2017.
The main violation stemmed from a labeling error: certain products within the affected batch incorrectly bore Chinese labels intended for "alanine aminotransferase assay dry tablets" on the packaging of the calcium assay product. While the product's intrinsic quality and machine readability via the original barcode were unaffected, the mislabeling presented a regulatory non-compliance. Approximately 499 boxes were identified with labeling errors, with 174 of these having been distributed to hospitals.
Operating under the NMPA's regulatory framework, the company is implementing comprehensive corrective actions. These include notifying all distributors and hospital customers in China regarding the labeling discrepancy. Distributors are mandated to rework labels on existing inventory, with sales of affected products strictly prohibited until corrections are complete. Hospital customers will also receive notifications to ensure necessary corrective measures are taken, upholding patient safety and regulatory adherence.

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