Siemens Healthcare Diagnostics, Inc.: ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11

Is my product affected?

ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11

• UPC 00630414501208

Check against the official notice below — it lists the full affected range.

What happened

Siemens Healthcare Diagnostics has recalled the ADVIA 2120 with Single Aspirate Autosampler (software versions 6.10 and 6.11) due to a potential sample identification mismatch when using 14-character barcodes. This automated hematology analyzer was distributed nationwide in the US as well as internationally to numerous countries.

The recall notice does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potential Sample Identification (SID) Mismatch with14-Character Barcodes

Details from the source

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: N/A Lot/code info: Software Versions 6.10 and 6.11 UDI: 00630414501208

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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