VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 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 affecting 45 units of the VITROS ECi/ECiQ Immunodiagnostic System worldwide, including locations in the US and 22 other countries. The affected devices have serial numbers 30005946, 30005947, 30005948, and 30005960 through 30006005 (with some numbers excluded). The systems are used to measure various substances in blood and other samples for diagnostic purposes.
The reason for the recall is a luminometer malfunction that may prevent the VITROS systems from processing MicroWell Assays. The product recall record 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: 45 units Lot/code info: Serial Numbers: 30005946, 30005947, 30005948, 30005960 through 30005975, 30005979 30005981 through 30005991 30005993, 30005994 30006000 through 30006005 UDI: 10758750000272
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.