The Recall Desk
HighFDA (Devices)·Z-1392-2021·Announced 2021-04-21

Siemens ADVIA 2120i Analyzer Recalled for Sample Identification Mismatch

Siemens Healthcare Diagnostics is recalling ADVIA 2120i automated hematology analyzers because 14-character barcodes may cause sample identification mismatches.

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 is classified as FDA Class II, and the hazard involves a risk of harm (sample identification mismatch) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA 2120i Refurb Single Aspirate automated hematology analyzer (SMN 11314044) in the United States and worldwide. The recall affects units running Software Versions 6.10 and 6.11. The devices are identified by UDI 00630414237879.

The recall is due to a potential Sample Identification (SID) mismatch associated with 14-character barcodes. This defect may result in incorrect sample identification during automated hematology testing. The agency has classified this as a Class II recall.

The affected devices were distributed in the United States and numerous countries worldwide, including Albania, Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bosnia Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, Colombia, Croatia, Curaçao, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French 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, Republic of Yemen, Republic of Korea, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Uruguay, Vatican City, and Vietnam. Healthcare facilities should contact Siemens Healthcare Diagnostics for further instructions on remediation.

The recalled product

Product
ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — Hematology Analyzer
Hazard
Affected units
1

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: 00630414237879

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.

See all →

Same hazard · sample identification mismatch

See all →