VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 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 25 refurbished VITROS ECi Immunodiagnostic Systems (Product Code 6801059) that were distributed worldwide, including throughout the United States and 22 other countries. The systems are used to perform laboratory measurements of various substances from patient samples. The recall affects systems that had their Luminometer component replaced during service or repair.
The issue is that the Luminometer may malfunction and prevent the system from processing MicroWell assays. The source does not specify what remedy affected consumers should pursue.
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: 25 units Lot/code info: Serial Numbers: Systems that had the Luminometer component replaced during a service-repair. UDI: 10758750001040
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.