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

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11

Is my product affected?

ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11

  • UPC 00630414581965

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

What happened

Siemens Healthcare Diagnostics is recalling 15 units of the ADVIA 2120i automated hematology analyzer with Single Aspirate Autosampler (model 10488923) running software versions 6.10 and 6.11. The recall addresses a potential sample identification mismatch issue that can occur when the device processes 14-character barcodes.

The affected devices have been distributed worldwide, including throughout the United States and in numerous countries across Europe, Asia, Africa, South America, and Oceania. The source document does not specify a remedy or recommended action for consumers who have this equipment.

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: 15 units Lot/code info: Software Versions 6.10 and 6.11 UDI: 00630414581965

Source

Official record: FDA (Device enforcement) ↗

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

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