# China NMPA Product Recall - High Sensitivity C Reactive Protein Calibrator (hsCRP CAL)

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthcare-diagnostics-inc/683b5e55-dcdd-40e1-bec0-40b29e796fdf/
Source feed: China

> China NMPA product recall for High Sensitivity C Reactive Protein Calibrator (hsCRP CAL) by Siemens Healthcare Diagnostics Inc. published December 11, 2019. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) issued an announcement regarding a voluntary Cla

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Healthcare Diagnostics Inc. is issuing a voluntary recall for its High Sensitivity C Reactive Protein Calibrator (hsCRP CAL) solution.
- Company Name: Siemens Healthcare Diagnostics Inc.
- Publication Date: 2019-12-11
- Product Name: High Sensitivity C Reactive Protein Calibrator (hsCRP CAL)
- Recall Level: Level 3 Recall
- Recall Reason: Problems where specific batches show deviations in inspection results, but quality control fails to detect them.
- Discovering Company: Siemens Medical Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Siemens Healthcare Diagnostics Inc.
- Summary: The National Medical Products Administration (NMPA) issued an announcement regarding a voluntary Class III recall initiated by Siemens Healthcare Diagnostics Inc. This recall pertains to specific batches of their High Sensitivity C Reactive Protein Calibrator (hsCRP CAL), which is registered under certificate number 20192400513. The issue, reported by Siemens Medical Diagnostics Products (Shanghai) Co., Ltd., centers on a critical performance deviation where certain product batches exhibited inaccurate results. Crucially, these deviations were undetectable through standard quality control procedures, posing a potential risk to patient diagnostics. Under the NMPA's regulatory oversight, Siemens Healthcare Diagnostics Inc. is undertaking this voluntary recall to address the product's non-conformance. The Class III designation indicates that the product issue is unlikely to cause adverse health consequences but still warrants corrective action. Further detailed information, including specific product models and batch numbers, is available in the accompanying 'Medical Device Recall Event Report Form'.

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