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FDA (Device enforcement)Recalled 2021-03-05class ii

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11

Is my product affected?

ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11

  • UPC 00630414019772

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

What happened

Siemens Healthcare Diagnostics has recalled 185 units of the ADVIA 2120i (RoHS) Dual Aspirate Autosampler automated hematology analyzer with software versions 6.10 and 6.11. The devices have been distributed worldwide, including throughout the United States and numerous countries. The recall was initiated due to a potential sample identification mismatch when processing 14-character barcodes, which could affect the accuracy of sample tracking and identification.

The source document does not specify a remedy or instructions for affected consumers regarding what action should be taken in response to this recall.

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: 185 units Lot/code info: Software Versions 6.10 and 6.11 UDI: 00630414019772

Source

Official record: FDA (Device enforcement) ↗

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

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