Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode 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 involves a risk of sample identification mismatch in a medical device, which poses a risk of harm without reported injuries, fitting the High severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA 2120i Refurb Dual Aspirate automated hematology analyzer, specifically units running Software Versions 6.10 and 6.11. The recall is due to a potential sample identification (SID) mismatch associated with 14-character barcodes.
The affected devices were distributed worldwide, including across the United States and numerous international markets. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare facilities using these analyzers should contact Siemens Healthcare Diagnostics for further instructions on how to address the barcode compatibility issue.
The recalled product
- Product
- ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- 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: 00630414237886
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.
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