Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch
Siemens is recalling 33 ADVIA 2120i automated hematology analyzers because a potential sample identification mismatch may occur 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 involves a risk-of-harm product (medical device) where a potential sample identification mismatch could lead to incorrect patient results, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 33 units of the ADVIA 2120i Refurb Single Aspirate automated hematology analyzer. The affected units are equipped with Software Versions 6.10 and 6.11. The recall is due to a potential sample identification (SID) mismatch that can occur when using 14-character barcodes.
The affected devices were distributed worldwide, including across the United States and numerous international locations. The source text does not specify the exact number of affected units in the United States or provide specific dates of distribution.
Healthcare facilities and users of these devices should contact Siemens Healthcare Diagnostics, Inc. for further instructions on how to resolve the issue. The source text does not provide specific contact details or remediation steps beyond the recall notice.
The recalled product
- Product
- ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 33
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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