# China NMPA Product Recall - Total thyroxine assay kit (chemiluminescence method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-tc2016-196/fac8b763-b62e-4a6d-aaf6-fe8a9e859908/
Source feed: China

> China NMPA product recall for Total thyroxine assay kit (chemiluminescence method) by Ortho-Clinical Diagnostics (TC2016-196) published August 30, 2016. Recall level: Level III. Ausendo Medical Devices Trading (China) Co., Ltd., on behalf of manufacturer Ortho-Clinical Diagnost

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling its total thyroxine assay kit (chemiluminescence method).
- Company Name: Ortho-Clinical Diagnostics (TC2016-196)
- Publication Date: 2016-08-30
- Product Name: Total thyroxine assay kit (chemiluminescence method)
- Recall Level: Level III
- Recall Reason: The shelf life of opened (in-use) total thyroxine assay kits (chemiluminescence immunoassay) must be reduced from 8 weeks to 4 weeks. This change will affect expired batches, current batches, and subsequent batches. Although these batches meet all factory inspection specifications before shipment, our testing indicates that negative bias may occur in test results obtained using total thyroxine assay kits (chemiluminescence immunoassay) that have been opened for more than 4 weeks.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics (TC2016-196)
- Summary: Ausendo Medical Devices Trading (China) Co., Ltd., on behalf of manufacturer Ortho-Clinical Diagnostics, initiated a Class III voluntary recall of its Total Thyroxine Assay Kit (Chemiluminescence Method). This action was reported by the National Medical Products Administration (NMPA) on August 30, 2016. The recall was prompted by the company's internal findings that test results from kits opened for more than four weeks could exhibit a negative deviation. The original recommended storage duration for opened kits was eight weeks, but subsequent testing revealed performance issues beyond four weeks.

This issue affects various product batches (including 1890, 1900, 1910, 1930, 1940, 1950, 1998) that were imported and sold globally, including in China. As a corrective measure, the permissible storage time for opened kits has been reduced from eight to four weeks. All customers using these kits have been notified of this critical change, impacting expired, current, and future product batches. The Instructions for Use (IFU) for the assay kit have been updated to reflect the new four-week storage requirement. Customers are instructed to retain the recall notice as proof of this change until the revised IFUs are fully distributed, underscoring the company's commitment to product accuracy and patient safety.

Company: https://www.globalkeysolutions.net/companies/ortho-clinical-diagnostics-tc2016-196/3fce0c14-c724-4647-a932-593127fb93e8/