# China NMPA Product Recall - dyeing machine

Source: https://www.keypedia.com/records/china_product_recall/sakura-seiki-co-ltd/07e75e52-405e-4087-beb6-386fe46e4ce3
Source feed: China

> China NMPA product recall for dyeing machine by Sakura Seiki Co., Ltd. published January 14, 2020. Recall level: Level 2 Recall. Sakura Seiki Co., Ltd., in collaboration with its agent Sakura Medical Technology (Taizhou) Co., Ltd

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Sakura Seiki., Ltd. voluntarily recalls dyeing machines.
- Company Name: Sakura Seiki Co., Ltd.
- Publication Date: 2020-01-14
- Product Name: dyeing machine
- Recall Level: Level 2 Recall
- Recall Reason: A malfunctioning CPU board on the control panel caused the instrument to sometimes suddenly stop operating. When the device suddenly stops and staining is interrupted, over-staining of the specimen may occur. However, even if over-staining occurs, the specimen can still be diagnosed if appropriate treatment is subsequently performed, and no significant health hazards will occur. To date, there have been no reports of health hazards caused by this incident.
- Discovering Company: Sakura Medical Technology (Taizhou) Co., Ltd.
- Manufacturing Company: Sakura Seiki Co., Ltd.
- Summary: Sakura Seiki Co., Ltd., in collaboration with its agent Sakura Medical Technology (Taizhou) Co., Ltd., issued a voluntary Class II recall for 65 staining machines (DRS-Prisma-P-JCS model) in China. This action was reported to the National Medical Products Administration (NMPA) on January 8, 2020, and publicly announced on January 14, 2020, to address a manufacturing defect. The core issue involves a faulty CPU board on the operating panel, causing the devices to unexpectedly stop during operation. This malfunction can lead to interrupted staining and potential over-staining of specimens. However, the company asserts that even over-stained specimens remain diagnosable after appropriate treatment, and no health-related incidents have been reported. Under the NMPA's regulatory guidance, Sakura Medical Technology (Taizhou) Co., Ltd. is implementing immediate corrective measures. These include dispatching customer letters to notify all affected parties and sending engineers to replace the defective CPU boards on the 62 units already sold, free of charge. The remaining three units in inventory will undergo CPU board replacement before they are made available for sale, ensuring full remediation of the product line.

Company: https://www.keypedia.com/companies/sakura-seiki-co-ltd/9aa9e85c-732a-4d22-ab7f-22dcf1d11087