Siemens ADVIA 2120 Hematology Analyzer Recalled for Sample Identification Mismatch
Siemens Healthcare Diagnostics is recalling ADVIA 2120 automated hematology analyzers due to potential 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 potential for sample identification errors, 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 the ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, an automated hematology analyzer. The recall affects units running Software Versions 6.10 and 6.11. The product has a UDI of 00630414501208.
The recall is issued because of a potential Sample Identification (SID) mismatch with 14-character barcodes. This issue could affect the accuracy of sample identification during automated processing.
The affected devices were distributed worldwide, including nationwide in the United States and in numerous other countries such as Albania, Algeria, Angola, Argentina, Australia, Austria, and many others. Healthcare facilities and laboratories using these specific software versions should contact Siemens Healthcare Diagnostics for further instructions on remediation or replacement.
The recalled product
- Product
- ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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: 00630414501208
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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