# China NMPA Product Recall - Fully automated blood typing analyzer

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-uk-ltd/2df4abf7-cc6c-4907-a8e1-899600011e32
Source feed: China

> China NMPA product recall for Fully automated blood typing analyzer by Ortho-Clinical Diagnostics (UK) Ltd. published July 14, 2023. Recall level: Level 2 Recall. Ortho-Clinical Diagnostics (UK) Ltd., supported by Ortho-Clinical Diagnostics Medical Device Trading

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ortho-Clinical Diagnostics (UK) Ltd. is voluntarily recalling its fully automated blood typing analyzer.
- Company Name: Ortho-Clinical Diagnostics (UK) Ltd.
- Publication Date: 2023-07-14
- Product Name: Fully automated blood typing analyzer
- Recall Level: Level 2 Recall
- Recall Reason: Incorrect regional settings configuration
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics (UK) Ltd.
- Summary: Ortho-Clinical Diagnostics (UK) Ltd., supported by Ortho-Clinical Diagnostics Medical Device Trading (China) Co., Ltd., has initiated a voluntary Class II recall of its fully automated blood typing analyzers. Published by the National Medical Products Administration (NMPA) on July 14, 2023 (Index No. JGXX-2023-10127), the recall addresses a critical manufacturing issue: incorrect regional settings within the devices. These affected analyzers are identified under National Medical Device Registration Certificates 20173222376 and 20173222355. The main concern is that these erroneous regional configurations could potentially compromise the accurate performance of the blood typing analyzers, presenting a risk of incorrect diagnostic results. A Class II recall indicates that the use of or exposure to the affected product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Under the NMPA's regulatory framework, the company's required action involves the proactive recall of specific affected models, specifications, and batches, as detailed in the "Medical Device Recall Event Report Form." This ensures compliance with medical device regulations and maintains the integrity of diagnostic testing equipment, safeguarding public health from potential misdiagnoses.

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