Siemens ADVIA 2120i Hematology Analyzer Recalled for Sample Identification Mismatch
Siemens is recalling 15 ADVIA 2120i automated hematology analyzers because a software defect may cause 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 is classified as FDA Class II, and the hazard involves potential diagnostic errors (sample identification mismatch) which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 15 units of the ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) automated hematology analyzer. The recall affects units running Software Versions 6.10 and 6.11. The devices were distributed worldwide, including across the United States and numerous international markets.
The recall was initiated due to a potential sample identification (SID) mismatch when using 14-character barcodes. This defect may result in incorrect sample identification, which could impact the accuracy of hematology test results. The agency has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
Healthcare facilities and laboratories that have these specific analyzer units should contact Siemens Healthcare Diagnostics, Inc. for further instructions on corrective actions. Consumers are not directly affected as this is a professional medical device used in clinical settings.
The recalled product
- Product
- ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 15
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: 00630414581965
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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