VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics, Inc. is recalling the VITROS XT 3400 Chemistry System with Version 3.7.2 and below (product code 6844458) due to a hazard affecting test result accuracy. When performing a system shutdown on these devices, an electrical current shift may occur in the LED used with the Digital Imaging Reflectometer, potentially causing reported results to shift in either a positive or negative direction.
The affected systems were distributed worldwide, including throughout the United States and in countries such as Australia, Canada, Japan, Germany, Brazil, China, and others. A total of 506 units are involved in this recall, identifiable by systems starting with "3400XXXX" where XXXX is unique for each analyzer. The source document does not specify a remedy or action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
Reason for recall: Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Brazil, Canada L3R 4G5 , Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom. Quantity: 506 units Lot/code info: UDI-DI: 10758750031986 Systems start with 3400XXXX where XXXX is unique for each analyzer
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.