# China NMPA Product Recall - α1-Microglobulin Detection Kit (Immunoturbidimetric Method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-gmbh/f60a68ef-bea9-4e73-83eb-12839c519b40/
Source feed: China

> China NMPA product recall for α1-Microglobulin Detection Kit (Immunoturbidimetric Method) by Roche Diagnostics GmbH published November 10, 2021. Recall level: Level 3 Recall. Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its "α1-Mi

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its α1-microglobulin detection kit (immunoturbidimetric assay).
- Company Name: Roche Diagnostics GmbH
- Publication Date: 2021-11-10
- Product Name: α1-Microglobulin Detection Kit (Immunoturbidimetric Method)
- Recall Level: Level 3 Recall
- Recall Reason: The imprecision of the α1-microglobulin assay kit (immunoturbidimetric method) has increased, and it no longer meets the product specification requirements.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics GmbH
- Summary: Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its "α1-Microglobulin Detection Kit (Immunoturbidimetric Assay)" on November 10, 2021. This action, reported by the Shanghai Municipal Drug Administration and overseen by the National Medical Products Administration (NMPA), stemmed from an internal company investigation. The investigation determined that the diagnostic kit's imprecision had increased, causing it to fail its established product specifications. The affected product is identified by Registration Certificate No.: 20172401204. The recall is classified as Class III, indicating that while the product's use is unlikely to cause serious adverse health consequences, the quality deviation requires its removal from the market to uphold product integrity and regulatory standards. Detailed information regarding specific product models, specifications, and batches involved is provided in the "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-gmbh/2a33a337-c39d-4329-b659-c812f690f94b/