# China NMPA Product Recall - Urine analysis sheath fluid

Source: https://www.globalkeysolutions.net/records/china_product_recall/beckman-coulter-experimental-systems-suzhou-co-ltd/143924b1-3889-44ac-a48f-2d64354263b5/
Source feed: China

> China NMPA product recall for Urine analysis sheath fluid by Beckman Coulter Experimental Systems (Suzhou) Co., Ltd. published June 27, 2022. Recall level: Level 3. Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. initiated a Level III voluntary recall for its

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. is proactively recalling sheath fluid for urine analysis.
- Company Name: Beckman Coulter Experimental Systems (Suzhou) Co., Ltd.
- Publication Date: 2022-06-27
- Product Name: Urine analysis sheath fluid
- Recall Level: Level 3
- Recall Reason: Some cartons for the sheath solution used in urine analysis were misused, specifically cartons for the washing solution. This is an incorrect situation. If the wrong cartons are used and the customer uses iQ Lamina as the iChem Velocity Wash Solution, erroneous results may occur.
- Discovering Company: Beckman Coulter Experimental Systems (Suzhou) Co., Ltd.
- Manufacturing Company: Beckman Coulter Experimental Systems (Suzhou) Co., Ltd.
- Summary: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. initiated a Level III voluntary recall for its Urine Analysis Sheath Fluid (iQ Lamina), reported by the National Medical Products Administration (NMPA) on June 27, 2022. The recall arose from the discovery that some cartons for the urine analysis sheath fluid had previously been used for iChem Velocity Wash Solution. While product labels attached to the cartons were accurate, the outer cartons occasionally displayed incorrect prior product information.

The main issue is the potential for customers to misidentify and incorrectly use iQ Lamina as iChem Velocity Wash Solution if relying solely on the outer carton. However, Beckman Coulter assessed the likelihood of this error as extremely low and the safety risk as low, primarily because the product caps for iQ Lamina are orange, and those for iChem Velocity Wash Solution are blue, offering clear visual differentiation.

Under NMPA's regulatory framework, Beckman Suzhou is implementing corrective actions by sending 

Company: https://www.globalkeysolutions.net/companies/beckman-coulter-experimental-systems-suzhou-co-ltd/b1bdab62-43a3-4af1-902c-04b2a6e0e660/