Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch
Siemens Healthcare is recalling 27 ADVIA 2120i hematology analyzers because a software defect may cause sample identification mismatches with 14-character barcodes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device with a risk of harm (sample identification mismatch) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 27 units of the ADVIA 2120i Refurb Dual Aspirate automated hematology analyzer. The affected units are running Software Versions 6.10 and 6.11. The recall is due to a potential sample identification (SID) mismatch that can occur when using 14-character barcodes.
The affected devices were distributed worldwide, including in the United States and numerous international markets. The source text does not specify the exact number of units distributed in each specific country, only the total count of 27 units and the general distribution scope.
Healthcare facilities and users of these analyzers should contact Siemens Healthcare Diagnostics, Inc. for further instructions on how to resolve the issue. The source text does not provide specific contact details or remediation steps, so users should refer to the official recall notice for guidance.
The recalled product
- Product
- ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 27
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
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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