# China NMPA Product Recall - Tripropylamine buffer, fully automated chemiluminescence immunoassay analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/b3f552de-9fbe-406d-a0f0-fbdcf1532ca9/
Source feed: China

> China NMPA product recall for Tripropylamine buffer, fully automated chemiluminescence immunoassay analyzer by Roche Diagnostics Products (Shanghai) Co., Ltd. published April 24, 2019. Recall level: Level 2 Recall. Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a Class II voluntary recall for its Tripro

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its Tripropylamine Buffer Solution and Fully Automated Chemiluminescence Immunoassay Analyzer.
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2019-04-24
- Product Name: Tripropylamine buffer, fully automated chemiluminescence immunoassay analyzer
- Recall Level: Level 2 Recall
- Recall Reason: The fully automated chemiluminescence immunoassay analyzer may experience signal degradation of the ProCell II M tripropylamine buffer due to bacterial contamination in the flow channel, and the cobase 801 module may exhibit signal decline only if at least two of the following conditions occur: 1. Bacterial contamination or other signs of contamination in the flow channel; 2. Failure to perform a daily [Finalization] operation; 3. The occurrence of the "ProCell On Board Stability Time (744-xxxxxx or 346-xxxxxx)" alarm; 4. The recurrence of the "Abnormal Signal Low (345-000001)" alarm; 5. The system has been running for more than 8 hours in CLAS connected mode or rack-mount receiver mode.
- 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 for its Tripropylamine Buffer and Fully Automated Chemiluminescence Immunoassay Analyzer, as reported to the National Medical Products Administration (NMPA) on April 24, 2019. The company's headquarters identified product quality issues during complaint assessments. Specifically, the ProCell II M tripropylamine buffer was found to degrade due to bacterial contamination within the analyzer's flow channel. This contamination, combined with other specific operating conditions such as failure to perform daily finalization, the occurrence of certain alarms (e.g., "ProCell On Board Stability Time," "Abnormal Signal Low"), or extended system operation in CLAS connection or rack receiving modes, could lead to signal degradation in the cobase 801 module. The recall addresses these potential performance compromises, ensuring product reliability and patient safety. Roche Diagnostics provided detailed information on affected models and batches in a Medical Device Recall Event Report Form. The NMPA website hosts this information, emphasizing compliance with medical device regulations.

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