VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics, Inc. is recalling the VITROS XT 7600 Integrated System with Version 3.7.2 and below (Product Code 6844461). The recall affects approximately 1,148 units that were distributed worldwide, including across the United States and countries such as Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and the United Kingdom. Affected systems have serial numbers starting with 7600XXXX, where XXXX is unique to each analyzer.
The hazard involves a potential shift in electrical current supplied to the LED used with the Digital Imaging Reflectometer when the system is shut down, which could cause positive or negative shifts in test results reported by the VITROS System. The source record does not specify a remedy or corrective 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: 1148 units Lot/code info: UDI-DI: 10758750031610 Systems start with 7600XXXX 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.