Siemens ADVIA 560 Hematology System Software Recall
Siemens is recalling ADVIA 560 Hematology Systems because a software defect prevents the system from flagging immature granulocytes and atypical lymphocytes in patient samples.
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 the hazard involves a diagnostic error (missing flags) that could lead to misdiagnosis or delayed treatment, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA 560 Hematology Systems (SMN 11170842) due to a software anomaly. The affected software version, 1.4.2133, fails to trigger specific morphology flags for immature granulocytes (IG) and atypical lymphocytes (ATYP). As a result, patient samples containing these cells may not generate the required flags, potentially affecting the accuracy of diagnostic results.
The recall affects 8 systems in the United States (including Puerto Rico and the states of California, Illinois, Washington, and Wisconsin) and 64 systems in foreign countries. The systems were distributed worldwide, including in Angola, Austria, Canada, Chile, Colombia, the Czech Republic, France, Germany, India, Italy, Kenya, the Netherlands, Norway, Portugal, Singapore, Slovenia, Spain, Turkey, Uganda, and the United Kingdom. All serial numbers of the ADVIA 560 Hematology System are included in this recall.
Clinical laboratories using these systems should contact Siemens Healthcare Diagnostics for further instructions on how to address the software issue. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories
- 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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