# China NMPA Product Recall - ORTHO VISION Fully Automated Blood Typing Analyzer, ORTHO VISION Max Fully Automated Blood Typing Analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/orsendo-medical-equipment-trading-china-co-ltd/108bdec7-6ace-4539-ba07-f9e82ae7abe0/
Source feed: China

> China NMPA product recall for ORTHO VISION Fully Automated Blood Typing Analyzer, ORTHO VISION Max Fully Automated Blood Typing Analyzer by Orsendo Medical Equipment Trading (China) Co., Ltd. published December 29, 2020. Recall level: Level 2 Recall. On December 29, 2020, ORTHO Medical Devices Trading (China) Co., Ltd. initiated a Class II voluntary

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling its fully automated blood typing analyzer.
- Company Name: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Publication Date: 2020-12-29
- Product Name: ORTHO VISION Fully Automated Blood Typing Analyzer, ORTHO VISION Max Fully Automated Blood Typing Analyzer
- Recall Level: Level 2 Recall
- Recall Reason: The ORTHO VISION and ORTHO VISION Max automated blood typing analyzers with software versions 5.12.8 or 5.13.0 have a software malfunction. This malfunction may occur when the pipette arm (PIPA) exits sleep mode, when one or more reagent or diluent vials are loaded into the analyzer, or when the operator enters maintenance mode before the automated blood typing analyzer completes reagent inventory.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Summary: On December 29, 2020, ORTHO Medical Devices Trading (China) Co., Ltd. initiated a Class II voluntary recall for its ORTHO VISION and Max fully automated blood typing analyzers. This action, overseen by the National Medical Products Administration (NMPA) and reported by the Shanghai Drug Administration, addresses a critical software malfunction. The issue, present in software versions 5.12.8 or 5.13.0, causes inappropriate pipette flushing. This can occur when the pipette arm exits sleep mode, during the loading of reagent or diluent vials, or if an operator accesses maintenance mode before the analyzer completes its reagent inventory. This defect compromises the analyzer's operational integrity. As a required action, the company has voluntarily recalled the affected medical devices, specifically those under Registration Certificate Nos.: 20173402355 and 20173402376. Further details on specific models, specifications, and batches are provided in the accompanying "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/orsendo-medical-equipment-trading-china-co-ltd/9d283785-b2ea-4291-8250-5927daf06726/