Siemens Atellica CH 930 Analyzer Recalled for Erroneous Hemolysis and Lipemia Indices
Siemens Healthcare Diagnostics is recalling 1,125 Atellica CH 930 Analyzers worldwide due to software errors that may produce incorrect hemolysis and lipemia indices.
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. The hazard involves erroneous diagnostic indices which may lead to incorrect clinical decisions, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,125 units of the Siemens Atellica CH 930 Analyzer, an automated clinical chemistry analyzer used for in vitro diagnostic tests. The recall affects units with software version V1.19.2 and below. The devices were distributed worldwide, including in the United States and numerous foreign countries.
The recall is due to a software defect that causes erroneous indices for hemolysis and lipemia. These indices are used to assess the quality of clinical specimens. Incorrect values may affect the interpretation of test results.
Healthcare facilities and users should contact Siemens Healthcare Diagnostics for instructions on how to resolve the issue. The agency has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,125
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 version: V1.19.2 and below
Distribution
Distributed nationwide across the United States.
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