# China NMPA Product Recall - Parathyroid hormone (1-84) assay kit (electrochemiluminescence assay)

Source: https://www.globalkeysolutions.net/records/china_product_recall/roche-diagnostics-products-shanghai-co-ltd/4e27323d-6fec-4861-9281-d38958f37af3/
Source feed: China

> China NMPA product recall for Parathyroid hormone (1-84) assay kit (electrochemiluminescence assay) by Roche Diagnostics Products (Shanghai) Co., Ltd. published August 19, 2020. Recall level: Level 2 Recall. On August 19, 2020, Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II r

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Roche Diagnostics Products (Shanghai) Co., Ltd. is voluntarily recalling its Parathyroid Hormone (1-84) Assay Kit (Electrochemiluminescence Assay).
- Company Name: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Publication Date: 2020-08-19
- Product Name: Parathyroid hormone (1-84) assay kit (electrochemiluminescence assay)
- Recall Level: Level 2 Recall
- Recall Reason: When calibrating a parathyroid hormone (1-84) assay kit (electrochemiluminescence immunoassay) with batch number 434933 on a cobas e601/e602 analyzer, the calibration signal at calibration level 2 fluctuated between ~25000 cts and ~35000 cts. This could lead to an overestimation or underestimation of the recovery rate in quality control results, thus affecting sample results. This phenomenon may occur when changing the batch number of the tripropylamine buffer. The effect of tripropylamine buffer on the parathyroid hormone (1-84) calibration signal differs between the cobas e601/e602 and e801 analyzers.
- Discovering Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Manufacturing Company: Roche Diagnostics Products (Shanghai) Co., Ltd.
- Summary: On August 19, 2020, Roche Diagnostics Products (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Parathyroid Hormone (1-84) Assay Kit (Electrochemiluminescence Imaging), specifically targeting batch number 434933. This action was prompted by customer complaints regarding significant calibration signal fluctuations on cobas e601/e602 analyzers. During calibration, the signal at level 2 was observed to vary considerably (between ~25000 cts and ~35000 cts), which could result in inaccurate quality control measurements and subsequently impact patient sample results. The issue is attributed to changes in the tripropylamine buffer batch and its differential effect on calibration signals across various analyzer models, affecting e601/e602 and e801, but not the cobas e411. No other assays are implicated. This voluntary recall is overseen by the National Medical Products Administration (NMPA) and reported through the Shanghai Municipal Drug Administration, demonstrating the company's commitment to addressing product quality concerns. Roche Diagnostics is taking proactive measures to remove the affected kits from distribution. Further details on specific product models and batches are provided in the "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/roche-diagnostics-products-shanghai-co-ltd/9b830c5b-8305-4f55-9e76-759151e7c7a9/