VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics has issued a recall of the VITROS 5600 Integrated System with Software V3.3.2 and below due to a luminometer malfunction that may prevent the system from processing MicroWell assays. The affected equipment includes 55 units with serial numbers 56003270 and above and has been distributed worldwide, including throughout the United States and in countries such as Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, and the United Kingdom.
The recall notice does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Reason for recall: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems Distribution: Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden,The Netherlands, and United Kingdom. Quantity: 55 units Lot/code info: Serial Numbers: 56003270 & above UDI: 10758750002740
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.