# China NMPA Product Recall - Low ionic strength salt solutions

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/1017f523-350b-4dc1-a443-dcc179080875/
Source feed: China

> China NMPA product recall for Low ionic strength salt solutions by Ortho-Clinical Diagnostics, Inc. published July 01, 2014. Recall level: . The National Medical Products Administration (NMPA) published a recall notice on July 1, 2014, conce

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ortho-Clinical Diagnostics, a UK-based company, is recalling low-ionic-strength salt solutions.
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2014-07-01
- Product Name: Low ionic strength salt solutions
- Recall Reason: The unopened bottle of low ionic strength salt solution, batch number 280397, contained mold (Cladosporium).
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: The National Medical Products Administration (NMPA) published a recall notice on July 1, 2014, concerning a voluntary recall initiated by Ortho-Clinical Diagnostics (UK) for a batch of its low ionic strength saline solution (Registration Certificate No.: CFDA (Imported) No. 20131403528). The report, submitted by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. on June 19, 2014 (reporting date June 17, 2014), detailed the discovery of mold, specifically Cladosporium spp., in unopened bottles of product batch number 280397. This specific solution, identified by model/specification 707116, is a critical component used with the Ortho BioVue® system for in vitro diagnostics. Crucially, the manufacturer confirmed that the affected batch (batch number 280397) had an import quantity of zero and was not sold within the Chinese market. Consequently, Johnson & Johnson (Shanghai) indicated that, beyond the initial notification to the State Food and Drug Administration, no further investigative or corrective actions, such as submitting evaluation reports, implementation plans, or summary reports, would be undertaken in China, given the absence of market exposure. Despite no sales in China, the NMPA proactively requested all provincial and municipal food and drug administrations to enhance their supervision and management over similar medical products to ensure ongoing safety and quality across the industry. This case illustrates a global recall with specific localized regulatory responses based on product distribution.

Company: https://www.globalkeysolutions.net/companies/ortho-clinical-diagnostics-inc/1aeceeb0-508e-4f89-ae53-22ef3ba7bd86/