Public recall detail

Coulter Dxh Diluent

2023-06-08

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Recall Safety notice
Quick summary

Quick summary: Coulter Dxh Diluent. Date: 2023-06-08.

Recommended action

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

Recall details

Quick summary: Coulter Dxh Diluent. Date: 2023-06-08.

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.
ProductCoulter Dxh Diluent
IssueMedical devices - Performance
Recall classType II
IdentificationRA-73762

Affected products

ProductCoulter Dxh Diluent
LotMore than 10 numbers, contact manufacturer.
Model628017
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCoulter Dxh Diluent

Issue

Beckman Coulter has confirmed that specific diluent lot numbers showed that conductivity, osmolality, and ph were out of manufacturing specifications. Quality control results may fail to flag for the affected parameters. Not all diluent containers within the affected lots exhibited the issue. Recall start date: May 29, 2023

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices
CompaniesBeckman Coulter, Inc. 250 S. Kraemer Blvd., Brea, California, United States, 92821
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-73762
Background{}
CompaniesBeckman Coulter, Inc. 250 S. Kraemer Blvd., Brea, California, United States, 92821
AudiencesHealthcare
Source updated2023-06-08

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

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