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

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinice-diagnostos/f37801ba-ccdc-4a43-9083-d95e4d677738/
Source feed: China

> China NMPA product recall for Calcium determination using dry slides (colorimetric method) by Ortho Clinice Diagnostos published April 17, 2017. Recall level: Level 3 Recall. Ausendo Medical Devices Trading (China) Co., Ltd., acting on behalf of manufacturer Ortho Clinice 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 Clinice Diagnostos
- Publication Date: 2017-04-17
- Product Name: Calcium determination using dry slides (colorimetric method)
- Recall Level: Level 3 Recall
- Recall Reason: Some products of this batch of calcium assay tablets (colorimetric method) in China were incorrectly labeled with Chinese tags indicating alanine aminotransferase (ALT) assay tablets (reverse rate method). During machine operation, because the machine reads the original barcode for product identification and does not involve the Chinese label, it will still identify the product as calcium assay tablets (colorimetric method) and perform subsequent testing as alanine aminotransferase (ALT) tablets, but will not perform the ALT assay (rapid method). The product quality itself is not affected, and based on regulatory compliance, Ausnutria has initiated corrective measures.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho Clinice Diagnostos
- Summary: Ausendo Medical Devices Trading (China) Co., Ltd., acting on behalf of manufacturer Ortho Clinice Diagnostos, initiated a Class III voluntary recall for its Calcium Assay Dry Tablets (Colorimetric Method). This recall, reported to the National Medical Products Administration (NMPA) on February 20, 2017, and publicly announced on April 17, 2017, was prompted by an incorrect labeling issue. A specific batch (033705385108) of Calcium Assay Dry Tablets, with 2030 boxes imported into China, was found to have Chinese labels for "Alanine Aminotransferase Assay Dry Tablets (Reverse Rate Method)" incorrectly applied to some units.

While the product's intrinsic quality remained unaffected and laboratory machines correctly identified the product using its original barcode, the misapplied Chinese label could potentially confuse users during manual operation, leading to incorrect test procedures for calcium determination. To address this, distributors were instructed to rework labels on existing inventory, with sales suspended until completion. Hospital customers who received affected products were promptly notified, and replacements were provided for all mislabeled units. These actions were taken to ensure regulatory compliance and prevent any user confusion stemming from the labeling discrepancy.

Company: https://www.globalkeysolutions.net/companies/ortho-clinice-diagnostos/e67eabb4-3804-4d6f-9788-f38fbf2085ff/