Siemens ADVIA 560 Hematology Systems Recalled for Incorrect Results
Siemens is recalling ADVIA 560 Hematology Systems because a database issue may cause multiple discordant records to be generated for the same sample, leading to incorrect results.
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 where a software defect could lead to incorrect diagnostic results, posing a risk of harm to patients, although no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA 560 Hematology Systems (Siemens Material Number 11170842) due to a potential issue that may cause incorrect results to be reported. The recall covers 23 systems in the United States and 141 systems in foreign countries. The affected units are distributed worldwide, including in specific US states and numerous international locations.
The recall was initiated after Siemens received two reports of multiple discordant records for the same Sample ID in the system's database during installation. The database is designed to contain only one record for a given Sample ID at a specific time and date. If multiple records exist for the same ID, it is possible that multiple results may be manually or automatically sent to the Laboratory Information System (LIS), printed, or displayed on the results report screen.
Siemens is investigating the issue. Users of the affected systems should contact Siemens Healthcare Diagnostics for further instructions on how to resolve the database discrepancy and ensure accurate reporting.
The recalled product
- Product
- ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
- 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)
- All serial numbers of ADVIA 560 Hematology Systems
Distribution
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