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

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/d30d88f7-56fd-481d-96ae-5f41737b6261/
Source feed: China

> China NMPA product recall for Phenytoin assay dry slides (immunorate rate method) by Ortho-Clinical Diagnostics, Inc. published January 18, 2011. Recall level: . Ortho-Clinical Diagnostics, Inc., in cooperation with Johnson & Johnson (Shanghai) Medical Devices C

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ortho-Clinical Diagnostics, Inc. of the United States is recalling phenytoin assay dry tablets (immunorate rate method).
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2011-01-18
- Product Name: Phenytoin assay dry slides (immunorate rate method)
- Recall Reason: Product testing accuracy is biased.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: Ortho-Clinical Diagnostics, Inc., in cooperation with Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary recall of its Phenytoin Assay Dry Tablets (Immunorate Method) with coat number 0115. The recall, overseen by China's National Medical Products Administration (NMPA), was triggered by a reported bias in the product's testing accuracy, as documented under its CFDA (Imported) registration. Johnson & Johnson (Shanghai) implemented comprehensive corrective actions. Starting November 16, 2010, they notified customers via email and telephone about the issue, halting further shipments of the affected batch and retrieving all identified products. The company reported a 100% effectiveness check for the recall, with all affected units corrected. The recall plan was fully executed and completed by November 23, 2010. No domestic customer complaints were received regarding this specific issue by the report date of November 29, 2010, underscoring a prompt and contained resolution to the product accuracy concern.

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