# China NMPA Product Recall - Phenobarbital assay dry slides (immunorate rate method)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/d4658ca0-08c9-4c64-a54a-26e43fcd0657/
Source feed: China

> China NMPA product recall for Phenobarbital assay dry slides (immunorate rate method) by Ortho-Clinical Diagnostics, Inc. published September 09, 2011. Recall level: . Ortho-Clinical Diagnostics, Inc., in cooperation with its Chinese representative Johnson & Johnson (

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ortho-Clinical Diagnostics, Inc., Inc., USA, is recalling phenobarbital assay dry tablets (immunorate rate assay).
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2011-09-09
- Product Name: Phenobarbital assay dry slides (immunorate rate method)
- Recall Reason: When using phenobarbital coating number 0053 to determine the quality control values of dry tablets, inaccurate, abnormal, and biased results sometimes occur.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: Ortho-Clinical Diagnostics, Inc., in cooperation with its Chinese representative Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary global recall of its Phenobarbital Assay Tablets (Immunometry). This action, reported on June 28, 2011, and publicized by the National Medical Products Administration (NMPA) on September 9, 2011, addresses critical quality control issues. The recall specifically targets products with coating number 0053, which were found to exhibit occasional inaccuracies, abnormalities, and deviations in quality control values. These tablets are designed for the quantitative determination of phenobarbital concentration in serum and plasma, indicating a potential impact on patient diagnostics and safety. The regulatory context for this imported medical device in China is governed by the NMPA, under registration certificate CFDA (Imported) No. 20093402271. In response to customer feedback and internal investigation, Ortho-Clinical Diagnostics confirmed the defect. Consequently, the company has mandated two primary corrective actions: immediately stopping the sale and destroying all remaining Phenobarbital Assay Tablets with coating number 0053, and recalling and destroying all previously sold units of this identified batch. This proactive measure aims to mitigate any risks associated with the faulty product.

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