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

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.11

Is my product affected?

ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.11

  • UPC 00630414581989

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

What happened

Siemens Healthcare Diagnostics is recalling 7 units of the ADVIA 2120 REFURB DAA AUTOSAMPLER (model 10374454) with software versions 6.10 and 6.11 that were distributed worldwide and throughout the United States. The recalled devices have a potential defect where sample identification (SID) could be mismatched with 14-character barcodes, which could affect the accuracy of sample processing and testing.

The recall source 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: 7 units Lot/code info: Software Versions 6.10 and 6.11 UDI: 00630414581989

Source

Official record: FDA (Device enforcement) ↗

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

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