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

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11

Is my product affected?

ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11

  • UPC 00630414581972

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

What happened

Siemens Healthcare Diagnostics has recalled one ADVIA 2120 REFURB SAA AUTOSAMPLER (model 10374453) with software versions 6.10 or 6.11. The device is an automated hematology analyzer that was distributed worldwide, including throughout the United States and numerous countries across Europe, Asia, Africa, South America, and the Middle East. The reason for the recall is a potential sample identification mismatch when using 14-character barcodes, which could result in incorrect sample identification during testing.

The recall notice does not specify a remedy or any required 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: 1 unit Lot/code info: Software Versions 6.10 and 6.11 UDI: 00630414581972

Source

Official record: FDA (Device enforcement) ↗

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

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