Automated Blood Coagulation Analyzers
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Automated Blood Coagulation Analyzer CN SERIES CN-3000 |
More than 10 numbers, contact manufacturer. |
BN343315 |
Automated Blood Coagulation Analyzer CN SERIES CN-3000 |
More than 10 numbers, contact manufacturer. |
CL971029 |
Automated Blood Coagulation Analyzer CN SERIES CN-6000 |
Q1079 |
AX801645 |
Automated Blood Coagulation Analyzer CN SERIES CN-6000 |
Q1078 |
AX801645 |
Automated Blood Coagulation Analyzer CN SERIES CN-6000 |
Q1079 |
CV339763 |
Automated Blood Coagulation Analyzer CN SERIES CN-6000 |
Q1078 |
CV339763 |
Issue
In October 2026, the legal manufacturer Sysmex notified Siemens Healthineers of an urgent field safety notice for the analyzer CN series systems.
Sysmex identified that deposits may accumulate on the sample arm B probe of the CN-series analyzers.
The deposits may affect sample dispensing, potentially resulting in the delivery of a lower sample volume to the reaction cuvette than defined, which and may cause falsely decreased results. Based on the manufacturer’s investigation, the accumulation of deposits occurred due to insufficient washing of the sample arm B probe independent from the assays used.
Additional information
Details
Sysmex Corporation
4-4-4- Takatsukadai, Kobe, Japan, 651-2271
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