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

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/30dbaa28-f34e-4cd8-a773-ecab3d1efe49/
Source feed: China

> China NMPA product recall for Phenytoin assay dry slides (immunorate rate method) by Ortho-Clinical Diagnostics, Inc. published September 04, 2014. Recall level: . The National Medical Products Administration (NMPA) issued a report on September 4, 2014, concerning

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ortho-Clinical Diagnostics, Inc., Inc., USA, is recalling phenytoin assay dry tablets (immunorate rate method).
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2014-09-04
- Product Name: Phenytoin assay dry slides (immunorate rate method)
- Recall Reason: Biased results may occur when using phenytoin assay dry tablets (immunorate rate method) batch number 2613-0150-4913. Some positive biased results were found during testing of different batches of phenytoin assay dry tablets (immunorate rate method).
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: The National Medical Products Administration (NMPA) issued a report on September 4, 2014, concerning a voluntary recall by Ortho-Clinical Diagnostics, Inc. for its Phenytoin Assay Dry Tablets (Immunometry), specifically batch number 2613-0150-4913. The recall, first reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. on August 28, 2014, addresses the potential for biased results, including positive biases. This issue could lead to inaccurate quantitative determination of phenytoin concentrations in patient serum and plasma when the product is used with various VITROS automated biochemical analyzers.

Operating under the NMPA's regulatory framework, referencing CFDA Import Permit No. 20122404635, the manufacturer initiated a global recall. However, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. verified that the affected batch was not sold or imported into the Chinese market. Therefore, beyond the initial notification to the NMPA, no additional recall actions, such as investigation plans or summary reports, will be undertaken by the distributor for products within China. Provincial food and drug administrations were instructed to enhance their supervision and management of similar medical devices to safeguard public health.

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