# China NMPA Product Recall - Fully automated blood typing analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-uk-ltd/9294edec-9d7c-413e-84ef-ba3a63bc7a32/
Source feed: China

> China NMPA product recall for Fully automated blood typing analyzer by Ortho-Clinical Diagnostics (UK) Ltd. published March 29, 2021. Recall level: Level 2 Recall. Ortho-Clinical Medical Devices Trading (China) Co., Ltd., in collaboration with Ortho-Clinical Diagn

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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: Ortho-Clinical Diagnostics (UK) Ltd.
- Publication Date: 2021-03-29
- Product Name: Fully automated blood typing analyzer
- Recall Level: Level 2 Recall
- Recall Reason: If a user creates a user-defined protocol (UDP) and modifies the dispensing amounts of one or more reactive components to achieve a total expected fill volume of 50 µL, 90 µL, or 100 µL, an error level (WLL) check may occur, resulting in a reported negative reaction.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics (UK) Ltd.
- Summary: Ortho-Clinical Medical Devices Trading (China) Co., Ltd., in collaboration with Ortho-Clinical Diagnostics, Inc. (UK) Ltd., has initiated a voluntary Class II recall of its fully automated blood typing analyzers (Registration Certificate Nos.: 20173402355; 20173402376). This action, publicly reported by the National Medical Products Administration (NMPA) on March 29, 2021, and the Shanghai Municipal Drug Administration on May 7, 2021, addresses critical performance issues with these medical devices. The primary issues identified involve unreliable liquid level (WLL) checks and the occurrence of negative reactions. These problems specifically arise when users create custom protocols (User-Defined Protocols) and modify the dispensing amounts of reaction components to achieve total expected filling volumes of 50uL, 90uL, or 100uL. Such technical malfunctions could potentially compromise the accuracy and reliability of blood typing results, posing risks to patient diagnostics. Operating under the NMPA's regulatory oversight, the company is undertaking this recall to rectify these product deficiencies and uphold stringent device efficacy and safety standards. Comprehensive details regarding the affected product models, specifications, and batch numbers are provided in the accompanying "Medical Device Recall Event Report Form" to guide stakeholders on necessary actions.

Company: https://www.globalkeysolutions.net/companies/ortho-clinical-diagnostics-uk-ltd/b2fef9e3-9688-40d0-8a6e-5df95438b736/