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

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/374dbe00-d0e5-4061-8bec-5b8cc1f1c913
Source feed: China

> China NMPA product recall for Total thyroxine assay kit (chemiluminescence method) and total thyroxine calibrators by Ortho-Clinical Diagnostics, Inc. published March 18, 2014. Recall level: . The National Medical Products Administration (NMPA) published an alert regarding the voluntary recal

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ortho Clinical Diagnostics, a UK-based company, is recalling its total thyroxine assay kits and calibrators.
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2014-03-18
- Product Name: Total thyroxine assay kit (chemiluminescence method) and total thyroxine calibrators
- Recall Reason: When using the total thyroxine assay kit (chemiluminescence method) of batch number 1590 to test quality control samples, there is a possibility that the test results will be lower than the expected values of the quality control samples. Similar situations may occur when testing patient samples. The OCD has also received reports of calibration failures for the total thyroxine calibrator of batch number 1590.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: The National Medical Products Administration (NMPA) published an alert regarding the voluntary recall of Total Thyroxine Assay Kits and Total Thyroxine Calibrators. The recall was initiated by the manufacturer, Ortho Clinical Diagnostics (UK), on March 3, 2014, and subsequently reported by its Chinese distributor, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., to the NMPA on March 6, 2014. The primary concern stemmed from potential quality issues with specific product models (1393396 and 8744468) and batch number 1590. Investigations revealed that the affected assay kits could produce test results for quality control products, and potentially patient samples, that were lower than expected. Additionally, calibration failures were reported for the corresponding calibrators from the same batch. This issue could lead to inaccurate diagnostic information for patients. The recall was enacted under the regulatory framework of the NMPA, with directives issued to provincial and municipal food and drug administrations to enhance supervision of such products in China. Ortho Clinical Diagnostics confirmed that its main action for these specific affected products, beyond the recall, was reporting to the State Drug Administration, with no further reports planned.

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