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

Siemens Healthcare Diagnostics, Inc.: ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11

Is my product affected?

ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11

  • UPC 00630414510309

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

What happened

Siemens Healthcare Diagnostics is recalling 32 units of the ADVIA 2120 Dual Aspirate Autosampler (model 10313419) with software versions 6.10 and 6.11 due to a potential sample identification mismatch when using 14-character barcodes. This automated hematology analyzer has been distributed worldwide, including throughout the United States and multiple international countries.

The hazard involves the possibility that sample identification could be mismatched when processing barcoded samples, which could affect test results. The recall source 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: 32 units Lot/code info: Software Versions 6.10 and 6.11 UDI: 00630414510309

Source

Official record: FDA (Device enforcement) ↗

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

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