Quick summary
Quick summary: Access PCT. Date: 2025-01-14.
Public recall detail
Access PCT
2025-01-14
Recall
Safety notice
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: Access PCT. Date: 2025-01-14.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandImmunotech S.A.S., A Beckman Coulter Company
ProductAccess PCT
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76829
Affected products
ProductAccess PCT
Lot439740
ModelC22593
Serial number439740
DescriptionAccess PCT
Issue
Beckman Coulter has determined that the affected Access PCT reagent lot is experiencing a high rate of calibration failures with a failure code of "max iterate" on Access 2 and UniCel DxI immunoassay systems. Recall start date: December 30, 2024
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesImmunotech S.A.S., A Beckman Coulter Company 130 Ave De Lattre De Tassigny,Bp177, Marseille, France, 13276
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76829
Background{}
CompaniesImmunotech S.A.S., A Beckman Coulter Company 130 Ave De Lattre De Tassigny,Bp177, Marseille, France, 13276
AudiencesHealthcare
Source updated2025-01-14
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
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