# China NMPA Product Recall - Ferritin Assay Kit (Heterogeneous Immunoassay) Ferritin Flex® reagent cartridge (FERR)

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthcare-diagnostics-inc/92689282-fee6-42ce-bb66-42bb154ce6e7/
Source feed: China

> China NMPA product recall for Ferritin Assay Kit (Heterogeneous Immunoassay) Ferritin Flex® reagent cartridge (FERR) by Siemens Healthcare Diagnostics Inc. published August 06, 2019. Recall level: Level 3 Recall. Siemens Healthcare Diagnostics Inc. has initiated a voluntary Class III recall concerning its Ferrit

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Healthcare Diagnostics Inc. is issuing a voluntary recall for its Ferritin Flex® reagent cartridge (FERR), a heterogeneous immunoassay kit.
- Company Name: Siemens Healthcare Diagnostics Inc.
- Publication Date: 2019-08-06
- Product Name: Ferritin Assay Kit (Heterogeneous Immunoassay) Ferritin Flex® reagent cartridge (FERR)
- Recall Level: Level 3 Recall
- Discovering Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Siemens Healthcare Diagnostics Inc.
- Summary: Siemens Healthcare Diagnostics Inc. has initiated a voluntary Class III recall concerning its Ferritin Flex® reagent cartridge (FERR), a critical component of the Ferritin Assay Kit (Heterogeneous Immunoassay). This significant regulatory action, communicated through the National Medical Products Administration (NMPA) and published on August 6, 2019, involves products distributed under National Medical Device Registration Certificate No. 20172401215. The recall was reported by Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. The primary reason for this recall is cited as "the existence of the product in question," indicating an identified issue requiring corrective action, though the specific nature of the defect is not detailed in this announcement. A Class III recall designation, as defined by regulatory standards, signifies that the use of or exposure to the affected medical device is not expected to cause serious adverse health consequences. The company's required action involves the proactive removal of the identified product from the market. Further comprehensive details, including the specific models, specifications, and batch numbers of the impacted Ferritin Flex® reagent cartridges, are documented within an attached "Medical Device Recall Event Report Form" to ensure complete transparency and traceability. This measure underscores the company's commitment to product safety and regulatory compliance within the medical device sector.

Company: https://www.globalkeysolutions.net/companies/siemens-healthcare-diagnostics-inc/4ca41d2b-8be7-40e5-b7e5-d9e3afdc8bce/