Siemens ADVIA 2120 Hematology Analyzer Recalled for Barcode Mismatch
Siemens Healthcare is recalling 132 ADVIA 2120 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. The hazard involves potential sample identification mismatches which could lead to incorrect medical results, representing a risk of harm where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 132 units of the ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, an automated hematology analyzer. The recall affects units running Software Versions 6.10 and 6.11. The devices were distributed worldwide, including in the United States and numerous other countries.
The recall is due to a potential sample identification (SID) mismatch when using 14-character barcodes. This defect could result in incorrect sample identification, which may lead to erroneous test results. 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, Inc. for further instructions on how to resolve the 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 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 132
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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