Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch
Siemens Healthcare Diagnostics is recalling 572 ADVIA 2120i automated hematology analyzers due to a potential sample identification mismatch 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. The hazard involves a potential sample identification mismatch, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 572 units of the ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, an automated hematology analyzer. The recall affects units running Software Versions 6.10 and 6.11. The devices were distributed worldwide, including the United States and numerous international markets.
The recall is issued because of a potential sample identification (SID) mismatch when using 14-character barcodes. This issue could lead to incorrect sample identification during the analysis process. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
Healthcare facilities and users of these devices should contact Siemens Healthcare Diagnostics for instructions on how to address the software issue. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 572
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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