# China NMPA Product Recall - Toxoplasma gondii IgM Assay Kit (Chemiluminescent Microparticle Immunoassay)

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-gmbh-co-kg/5af63d73-ec18-4cbb-bf47-e6cd655b626a/
Source feed: China

> China NMPA product recall for Toxoplasma gondii IgM Assay Kit (Chemiluminescent Microparticle Immunoassay) by Abbott GmbH & Co. KG published December 29, 2016. Recall level: Level 2 Recall. Abbott Trading (Shanghai) Co., Ltd., the Chinese operational unit for manufacturer Abbott GmbH & Co.

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Trading (Shanghai) Co., Ltd. is voluntarily recalling its Toxoplasma gondii IgM assay kit (chemiluminescent microparticle immunoassay).
- Company Name: Abbott GmbH & Co. KG
- Publication Date: 2016-12-29
- Product Name: Toxoplasma gondii IgM Assay Kit (Chemiluminescent Microparticle Immunoassay)
- Recall Level: Level 2 Recall
- Recall Reason: Internally, it was found that testing with Toxoplasma gondii IgM assay kits from immunocompromised patients, newborns, or umbilical cord blood samples with low titers of IgM may cause an increase in gray zones and/or false reactive results.
- Discovering Company: Abbott Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott GmbH & Co. KG
- Summary: Abbott Trading (Shanghai) Co., Ltd., the Chinese operational unit for manufacturer Abbott GmbH & Co. KG, initiated a voluntary Class II recall concerning specific batches of its Toxoplasma IgM Assay Kit (Chemiluminescent Microparticle Immunoassay). Reported on November 18, 2016, and published by the National Medical Products Administration (NMPA) on December 29, 2016, this action addresses a significant product performance issue. The primary concern is that the assay kit, registered under NMPA No. 20163401701, may produce "gray areas" or "false reactive results" when testing low-titer IgM samples from immunocompromised patients, newborns, or umbilical cord blood. This defect poses a risk of misdiagnosis for these vulnerable groups, although samples from pregnant women and blood donors remain unaffected. As required by the NMPA framework, Abbott's corrective actions include immediately notifying all affected customers via a detailed letter. Customers are permitted to continue using the kits, provided they adhere to the instructions within the notification, indicating specific precautions for at-risk populations. The company has also committed to an internal investigation and implementing further corrective measures.

Company: https://www.globalkeysolutions.net/companies/abbott-gmbh-co-kg/4f044062-9d39-4cdc-b5fe-03ef6c5de7f8/