Siemens ADVIA 2120 Autosampler Recalled for Barcode Mismatch
Siemens is recalling 7 ADVIA 2120 automated hematology analyzers 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 is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 7 units of the ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) 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 other countries.
The recall is being issued because of a potential sample identification (SID) mismatch with 14-character barcodes. This issue could affect the accuracy of sample identification on the device.
Healthcare facilities and users of the affected analyzers should contact Siemens Healthcare Diagnostics, Inc. for further instructions on how to resolve the issue. The recall is classified as Class II by the FDA.
The recalled product
- Product
- ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Versions 6.10 and 6.11
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 7
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: 00630414581989
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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