Beckman Coulter Inc. iChemVELOCITY Urine Chemistry System- Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

A defect in the SATA power adapter cable within the instruments computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computers metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the devices CD-ROM.

Recommended Action

Per FDA guidance

On 03/25/2020 Beckman Coulter Inc. sent out Urgent Medical Device Alert identifying the problem, the circumstances in which it can occur, the actions that should be taken by the customer/user in order to prevent risks to patients or users, and the actions planned by Beckman Coulter to correct the problem. PRODUCTS: Products installed between July of 2012 and December of 2014 are in scope of this field corrective action and can be identified by the name of the Product (all part numbers) that were installed in the time frames noted. ACTION TO BE TAKEN BY CUSTOMER/USER: If flames and or smoke be detected within the computer the customers/users should; follow laboratorys safety guidelines, contact Beckman Coulter by phone: call 800-526-7694 in the United States and Canada or if outside the United States and Canada, contact Beckman Coulter hotline or the local Beckman Coulter representative, and Follow Standard Operating Procedures (SOP) for Instrument backup testing methodology. This information should be communicated to all laboratory staff and retained as part of lab quality system documentation. Customers are asked to complete the Notification Response Form either electronically or manually depending on the method the notice was received. ACTIONS PLANNED BY BECKMAN COULTER: A Beckman Coulter service provider will proactively schedule a service visit to inspect the PC6 computer and replace the affected cable, if necessary. Additional potentially affected customers will be notified of the issue via Updated Urgent Medical Device Recall letter that will be sent during the week of 10/26/2020 via mail and/or e-mail. Note: Customers that received the initial letter but have any of the additional potentially affected devices will be re-notified of the issue.