VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 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 is recalling 28 refurbished VITROS 3600 Immunoassay Systems with Software V3.3.2 and below (Product Code 6802914). These systems are used for in vitro quantitative, semi-quantitative, and qualitative measurements. The affected units are those that had the Luminometer replaced during a service-repair and were distributed worldwide, including throughout the United States and 23 other countries including Australia, Canada, Japan, and the United Kingdom.
The recall addresses a malfunction in the Luminometer that may cause an inability to process MicroWell Assays on VITROS systems. The source does not specify a remedy or corrective action that affected consumers should take.
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: 28 UNITS Lot/code info: Serial Numbers: Affects systems that had the Luminometer replaced during a service-repair UDI:10758750007103
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.