Health product recall

Automated Blood Coagulation Analyzers

Last updated

Summary

Product
Automated Blood Coagulation Analyzers
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies

Sysmex Corporation

4-4-4- Takatsukadai, Kobe, Japan, 651-2271

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82927

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