# China NMPA Product Recall - Carbohydrate Antigen 19-9 Assay Kit (Electrochemiluminescence Assay) (Elecsys CA19-9)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/56ebf981-a492-4ae9-afbd-212ac343fc6e
Source feed: China

> China NMPA product recall for Carbohydrate Antigen 19-9 Assay Kit (Electrochemiluminescence Assay) (Elecsys CA19-9) by Roche Diagnostics Products (Shanghai) Co., Ltd. published April 17, 2020. Recall level: Level 2 Recall. Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a Class II voluntary recall of specific ba

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its Carbohydrate Antigen 19-9 Assay Kit (Electrochemiluminescence Assay).
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2020-04-17
- Product Name: Carbohydrate Antigen 19-9 Assay Kit (Electrochemiluminescence Assay) (Elecsys CA19-9)
- Recall Level: Level 2 Recall
- Recall Reason: Recently, there has been an increase in complaints regarding non-reproducible high flyers on the cobas e 801 platform for batch number 416245 of the Carbohydrate Antigen 19-9 Assay Kit (electrochemiluminescence assay). This issue may affect clinical interpretation. While the upcoming batch number 464449 of the same product has a lower incidence of high flyers, it is still affected.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a Class II voluntary recall of specific batches of its Carbohydrate Antigen 19-9 Assay Kit (Elecsys CA19-9) for Electrochemiluminescence Imaging. This action, reported to the National Medical Products Administration (NMPA) on April 17, 2020, addresses a significant issue identified with the product. The main problem involves an increase in complaints regarding non-reproducible "high flyers" observed when using batch number 416245 on the cobas e 801 platform. This defect has the potential to adversely affect clinical interpretation. Additionally, an upcoming batch, 464449, was also identified as being affected, albeit with a lower reported incidence rate of the "high flyer" issue. It is important to note that Elecsys CA19-9 test kits utilized on cobas e411, e601, and e602 platforms are not impacted by this problem. The company is taking proactive steps to recall the affected assay kits, identified by Registration Certificate No. 20143405201, to uphold product reliability and patient safety. Further details regarding specific affected models, specifications, and batch numbers are provided in the "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-products-shanghai-co-ltd/9b830c5b-8305-4f55-9e76-759151e7c7a9