ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics has recalled one ADVIA 2120i Refurb Dual Aspirate automated hematology analyzer (model 11314045) with software versions 6.10 or 6.11 due to a potential sample identification mismatch issue with 14-character barcodes. The affected unit was distributed worldwide, including throughout the United States and numerous other countries.
The sample identification mismatch could potentially cause incorrect matching between samples and their associated test results. The record does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Reason for recall: Potential Sample Identification (SID) Mismatch with14-Character Barcodes Distribution: Worldwide distribution - US Nationwide distribution and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bosnia Herzeg., Botswana, Brazil, Bulgaria, Burkina, Faso, Cambodia, Canada, Chile, Colombia, Croatia, Cura¿ao Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Fren.Polynesia, Georgia, Germany, G Quantity: 1 unit Lot/code info: Software Versions 6.10 and 6.11 UDI: 00630414237886
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.