# China NMPA Product Recall - Fully automated blood gas, electrolyte and biochemical analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-gmbh/8993ad7e-aa68-4b19-ba8a-bfcd046f4428/
Source feed: China

> China NMPA product recall for Fully automated blood gas, electrolyte and biochemical analyzer by Roche Diagnostics GmbH published April 24, 2015. Recall level: Level II. On April 24, 2015, Roche Diagnostics Products (Shanghai) Co., Ltd., representing Roche Diagnostics G

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its fully automated blood gas, electrolyte, and biochemical analyzers.
- Company Name: Roche Diagnostics GmbH
- Publication Date: 2015-04-24
- Product Name: Fully automated blood gas, electrolyte and biochemical analyzer
- Recall Level: Level II
- Recall Reason: When using the fully automated cobas b 123 POC blood gas, electrolyte, and biochemical analyzer to test neonatal blood samples containing cellular microparticles, elevated total bilirubin levels may be obtained. If total hemoglobin (tHb) and hematocrit (Hct) parameters are not simultaneously measured, the elevated bilirubin levels are less likely to be detected. The current version of the instruction manual, V9.0, does not clearly explain the necessity of measuring these parameters for bilirubin testing in neonatal blood samples.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics GmbH
- Summary: On April 24, 2015, Roche Diagnostics Products (Shanghai) Co., Ltd., representing Roche Diagnostics GmbH, Germany, initiated a voluntary Class II recall for its Fully Automated Blood Gas, Electrolyte, and Biochemical Analyzers, specifically the cobas b 123 POC systems. This action, overseen by the National Medical Products Administration (NMPA) under registration number CFDA (Imported) No. 20142404167, addressed a significant product issue identified through customer feedback.

The core problem involved the analyzer's tendency to produce elevated total bilirubin results when testing neonatal blood samples that contained cellular microparticles. A critical concern was that these elevated results could be difficult to detect if total hemoglobin and hematocrit parameters were not measured concurrently. The existing instruction manual (Version 9.0) was found to be deficient, as it did not clearly explain the necessity of these simultaneous parameter measurements for accurate neonatal bilirubin assessment.

In response, Roche committed to several corrective actions. These included issuing notification letters to both current and new users of the affected products, informing them of the incident and necessary operational precautions. Additionally, the company identified the root cause of the anomaly and pledged to revise the product's instruction manual to incorporate explicit instructions and clarifications, thereby enhancing user guidance and safeguarding patient safety.

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