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

Source: https://www.globalkeysolutions.net/records/china_product_recall/ortho-clinical-diagnostics-inc/43d8f984-21fc-400e-90b3-2ade164b401e/
Source feed: China

> China NMPA product recall for Phenytoin assay dry slides (immunorate rate method) by Ortho-Clinical Diagnostics, Inc. published July 27, 2017. Recall level: Level 2. Ausendo Medical Devices Trading (China) Co., Ltd., acting as the agent for manufacturer Ortho-Clinic

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Orsendo Medical Devices Trading (China) Co., Ltd. is voluntarily recalling phenytoin assay dry tablets (immunoassay method).
- Company Name: Ortho-Clinical Diagnostics, Inc.
- Publication Date: 2017-07-27
- Product Name: Phenytoin assay dry slides (immunorate rate method)
- Recall Level: Level 2
- Recall Reason: Ortho Clinical Diagnostics (Ortho) has determined that negative bias may occur when testing citrate plasma samples using phenytoin assay dry strips (immunorate rate method). The bias is primarily due to the dilution effect of the liquid anticoagulant in the citrate plasma tubes. No biased results were observed in serum and/or heparinized plasma samples obtained from the same patients.
- Discovering Company: Orsendo Medical Equipment Trading (China) Co., Ltd.
- Manufacturing Company: Ortho-Clinical Diagnostics, Inc.
- Summary: Ausendo Medical Devices Trading (China) Co., Ltd., acting as the agent for manufacturer Ortho-Clinical Diagnostics, Inc., initiated a voluntary Class II recall for its Phenytoin Assay Dry Tablets (Immunometry). The National Medical Products Administration (NMPA) published this recall (Index No.: JGXX-2017-10714) on July 27, 2017, following a report submitted on July 3, 2017.
The primary issue identified was a negative bias occurring when the assay was used to test citrate plasma samples. This inaccuracy was attributed to the dilution effect of the liquid anticoagulant present in citrate plasma tubes, potentially leading to understated phenytoin content results. Importantly, serum and heparinized plasma samples from the same patients did not exhibit this bias. The product is designed for quantitative determination of phenytoin in serum and plasma, with 11 boxes sold in China out of 21 imported.
As a corrective action, customers worldwide have been instructed to immediately cease using citrate plasma samples with the Phenytoin Assay Dry Tablets. However, the product remains suitable for use with heparinized plasma or serum samples. Ortho-Clinical Diagnostics plans to issue a notice after revising the product's instructions for use, explicitly removing citrate plasma from the list of recommended sample types to ensure accurate diagnostic outcomes.

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