Public recall detail

Synchron® Systems Direct LDL Cholesterol (LDLD) Reagent

2025-09-25

medium
Recall Safety notice
Quick summary

Quick summary: Synchron® Systems Direct LDL Cholesterol (LDLD) Reagent. Date: 2025-09-25.

Recommended action

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

Recall details

Quick summary: Synchron® Systems Direct LDL Cholesterol (LDLD) Reagent. Date: 2025-09-25.

Official details

Affected product details

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

BrandBECKMAN COULTER, INC.
ProductSynchron® Systems Direct LDL Cholesterol (LDLD) Reagent
IssueMedical devices - Performance
Recall classType II
IdentificationRA-78132

Affected products

ProductSynchron® Systems Direct LDL Cholesterol (LDLD) Reagent
LotM404166
Model969706
Serial numberM404166
DescriptionSynchron® Systems Direct LDL Cholesterol (LDLD) Reagent

Issue

Beckman Coulter has determined that there is an increased probability Synchron® Systems Direct LDL Cholesterol (LDLD ref 969706) reagent lot m404166 may generate false high results.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - Chemistry
CompaniesBeckman Coulter, Inc. 250 S. Kraemer Blvd., Brea, California, United States, 92821
Recall date2025-09-10
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-78132
Background{}
CompaniesBeckman Coulter, Inc. 250 S. Kraemer Blvd., Brea, California, United States, 92821
AudiencesHealthcare Industry
Source updated2025-09-25

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

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