ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - 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 8 units of the ADVIA 2120i (RoHS) automated hematology analyzer with Single Aspirate Autosampler (software versions 6.10 and 6.11) due to a potential sample identification mismatch when using 14-character barcodes. This device has been distributed nationwide in the US and to numerous countries worldwide.
The recall affects units with the specified software versions and UDI 00630414019789. The source document 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: 8 units Lot/code info: Software Versions 6.10 and 6.11 UDI: 00630414019789
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.