The Recall Desk
HighFDA (Devices)·Z-1395-2021·Announced 2021-04-21

Siemens ADVIA 2120i Autosampler Recalled for Barcode Mismatch

Siemens Healthcare Diagnostics is recalling 185 ADVIA 2120i Dual Aspirate Autosamplers due to potential sample identification mismatches with 14-character barcodes.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential sample identification errors.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 185 units of the ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer. The recall affects units running Software Versions 6.10 and 6.11. The product is identified by UDI 00630414019772.

The recall is issued because of a potential Sample Identification (SID) mismatch with 14-character barcodes. This issue could affect the accuracy of sample identification in the automated hematology analyzer.

The affected units were distributed worldwide, including nationwide in the United States and in numerous other countries such as 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, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Mali, Malta, Martinique, Mexico, Namibia, Netherlands, Norway, Oman, P.R. China, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad,Tobago, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Uruguay, Vatikancity, and Vietnam.

The recalled product

Product
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — Hematology Analyzer
Hazard
Affected units
185

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Software Versions 6.10 and 6.11 UDI: 00630414019772

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 20 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 20 products in this recall →

Related recalls

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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Same hazard · sample identification error

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