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

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer Software Versions 6.10 and 6.11

Is my product affected?

ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer Software Versions 6.10 and 6.11

  • UPC 00630414560045

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

What happened

Siemens Healthcare Diagnostics has recalled 187 units of the ADVIA 2120i Dual Aspirate Autosampler (model 10285573) with software versions 6.10 and 6.11 due to a potential sample identification mismatch when processing 14-character barcodes. This automated hematology analyzer was distributed worldwide, including throughout the United States and numerous countries across Europe, Africa, Asia, South America, Australia, and the Pacific region.

The sample identification mismatch could potentially affect the accuracy of patient test results if samples are incorrectly matched to patient information during the analysis process. The source document does not specify a remedy or recommended 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: 187 units Lot/code info: Software Versions 6.10 and 6.11 UDI: 00630414560045

Source

Official record: FDA (Device enforcement) ↗

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

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