Alerta De Seguridad para Trade name: iChem VELOCITY Technical name: Urine Analyzer Instrument ANVISA Registration Number: 10033129046 Hazard Class: I Affected Model: Serial Numbers Affected: All instrument serial numbers in Brazil are affected by this notification.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

• Avoid hitting the probe during maintenance or troubleshooting. • Carefully follow the instructions in the Operator's Manual, PN 301-7146 or 300-4449, to: - Use the Probe Safety Latch. - Use approved pipe types. - Remove tube caps prior to sample analysis to avoid probe-tube collisions. • As a temporary measure, perform a patient cross-check or perform QA after performing maintenance or troubleshooting in the sample probe area. If you have any questions about the results, please contact our Customer Service Center. • Consult the Laboratory Director to determine if a retrospective review of the results is medically justified.