VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 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 recalled the VITROS 5600 Integrated System Refurbished (software version 3.3.2 and below) due to a luminometer malfunction that may prevent the system from processing MicroWell assays. The affected equipment consists of 4 units worldwide that had their luminometer replaced during service or repair, identified by serial numbers in the UDI 10758750007110. The recalled systems have been distributed throughout the United States and internationally to Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, the Netherlands, and the United Kingdom.
The source document does not specify what actions affected consumers should take in response to this recall.
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: 4 units Lot/code info: Serial Numbers: Affects systems that had the Luminometer replaced during a service-repair UDI: 10758750007110
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.