Public recall detail

Automated Blood Coagulation Analyzers

2026-11-06

medium
Health products Health product recall
Quick summary

Quick summary: Automated Blood Coagulation Analyzers. Reason: Health product recall. Category: Health products. Date: 2026-11-06.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Automated Blood Coagulation Analyzers. Reason: Health product recall. Category: Health products. Date: 2026-11-06.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandSysmex Corporation
ProductAutomated Blood Coagulation Analyzers
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82927

Affected products

ProductAutomated Blood Coagulation Analyzer CN SERIES CN-3000
LotMore than 10 numbers, contact manufacturer.
ModelBN343315
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAutomated Blood Coagulation Analyzer CN SERIES CN-3000
ProductAutomated Blood Coagulation Analyzer CN SERIES CN-3000
LotMore than 10 numbers, contact manufacturer.
ModelCL971029
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAutomated Blood Coagulation Analyzer CN SERIES CN-3000
ProductAutomated Blood Coagulation Analyzer CN SERIES CN-6000
LotQ1079
ModelAX801645
Serial numberQ1079
DescriptionAutomated Blood Coagulation Analyzer CN SERIES CN-6000
ProductAutomated Blood Coagulation Analyzer CN SERIES CN-6000
LotQ1078
ModelAX801645
Serial numberQ1078
DescriptionAutomated Blood Coagulation Analyzer CN SERIES CN-6000
ProductAutomated Blood Coagulation Analyzer CN SERIES CN-6000
LotQ1079
ModelCV339763
Serial numberQ1079
DescriptionAutomated Blood Coagulation Analyzer CN SERIES CN-6000
ProductAutomated Blood Coagulation Analyzer CN SERIES CN-6000
LotQ1078
ModelCV339763
Serial numberQ1078
DescriptionAutomated Blood Coagulation Analyzer CN SERIES CN-6000

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Haematology
CompaniesSysmex Corporation 4-4-4- Takatsukadai, Kobe, Japan, 651-2271
Recall date2026-10-29
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82927
Original published date2026-11-06
Background{}
CompaniesSysmex Corporation 4-4-4- Takatsukadai, Kobe, Japan, 651-2271
AudiencesHealthcare
Source updated2026-11-06

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

Official source Monitor products Back to recalls

Starting...

Related recalls

Similar recalls and safety notices.

Loading related recalls...