Siemens ADVIA 2120 Autosampler Recalled for Sample Identification Mismatch
Siemens is recalling 32 ADVIA 2120 Dual Aspirate Autosamplers due to a potential sample identification mismatch 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 risk of harm (sample identification mismatch) where specific injury or illness reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 32 units of the ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, an automated hematology analyzer. The recall affects units running Software Versions 6.10 and 6.11. The product is identified by UDI 00630414510309.
The recall is issued because of a potential sample identification (SID) mismatch with 14-character barcodes. This issue could affect the accurate identification of samples processed by the device.
The affected units were distributed worldwide, including nationwide in the United States and in numerous other countries. Siemens Healthcare Diagnostics, Inc. is the recalling firm.
The recalled product
- Product
- ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 32
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: 00630414510309
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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