Siemens ADVIA 2120 Autosampler Recalled for Barcode Mismatch
Siemens Healthcare is recalling 283 ADVIA 2120 Dual Aspirate Autosamplers 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, and the hazard involves a risk of harm (incorrect sample identification) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 283 units of the ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, an automated hematology analyzer. The recall affects units running Software Versions 6.10 and 6.11. The product was 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 automated hematology analysis.
Healthcare facilities and users of the affected devices should contact Siemens Healthcare Diagnostics for further instructions on how to address the software issue. No specific instructions for end-consumers are provided as this is a professional medical device.
The recalled product
- Product
- ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 283
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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