Siemens ADVIA 2120i Hematology Analyzer Recalled for Barcode Mismatch
Siemens Healthcare Diagnostics is recalling 8 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 involves a medical device with a potential for diagnostic error (sample identification mismatch), which poses a risk of harm to patients if incorrect results are used for clinical decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 8 units of the ADVIA 2120i (RoHS) automated hematology analyzer with Single Aspirate Autosampler (SMN 11219529) in the United States. The recall affects units running Software Versions 6.10 and 6.11. The product is identified by UDI 00630414019789.
The recall is being conducted because of a potential Sample Identification (SID) mismatch with 14-character barcodes. This issue could affect the accuracy of sample identification during automated hematology analysis.
The affected units were distributed worldwide, including nationwide distribution in the United States and in numerous other countries. Siemens Healthcare Diagnostics, Inc. is the recalling firm responsible for addressing this issue.
The recalled product
- Product
- ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.11
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 8
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: 00630414019789
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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