Public recall detail

UniCel DxI 600 & 800 Systems

2025-07-16

medium
Recall Safety notice
Quick summary

Quick summary: UniCel DxI 600 & 800 Systems. Date: 2025-07-16.

Recommended action

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

Recall details

Quick summary: UniCel DxI 600 & 800 Systems. Date: 2025-07-16.

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.
ProductUniCel DxI 600 & 800 Systems
IssueMedical devices - Performance
Recall classType II
IdentificationRA-77731

Affected products

ProductUniCel DxI 600 Access Immunoassay Analyzer
Lot902386
ModelA30260
Serial number902386
DescriptionUniCel DxI 600 Access Immunoassay Analyzer
ProductUniCel DxI 600 Access Immunoassay Analyzer
Lot902624
ModelA30260
Serial number902624
DescriptionUniCel DxI 600 Access Immunoassay Analyzer
ProductUniCel DxI 600 Access Immunoassay Analyzer
Lot902385
ModelA30260
Serial number902385
DescriptionUniCel DxI 600 Access Immunoassay Analyzer
ProductUniCel DxI 600 Access Immunoassay Analyzer
Lot902622
ModelA30260
Serial number902622
DescriptionUniCel DxI 600 Access Immunoassay Analyzer
ProductUniCel DxI 600 Access Immunoassay Analyzer
Lot902475
ModelA30260
Serial number902475
DescriptionUniCel DxI 600 Access Immunoassay Analyzer
ProductDxI 600 Access Immunoassay W/Spot B
LotMore than 10 numbers, contact manufacturer.
ModelA71460
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionDxI 600 Access Immunoassay W/Spot B
ProductUniCel DxI 800 Access Immunoassay Analyzer
Lot609576
Model973100
Serial number609576
DescriptionUniCel DxI 800 Access Immunoassay Analyzer

Issue

Beckman identified an issue on UniCel DxI 600 & 800 Systems with linear slide pnp gantries running software versions 5.7 and up. During installs or upgrades, the Beckman identified an issue on UniCel DxI 600 & 800 Systems with linear slide pnp gantries running software versions 5.7 and up. During installs or upgrades, the pnp xmotor current incorrectly resets to 1.5a (instead of the required 2.0a) because the software overwrites the factory setting, causing increased pnp motion errors. current incorrectly resets to 1.5a (instead of the required 2.0a) because the software overwrites the factory setting, causing increased pnp motion errors. Recall start date: June 18, 2025

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
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-77731
Background{}
CompaniesBeckman Coulter, Inc. 250 S. Kraemer Blvd., Brea, California, United States, 92821
AudiencesHealthcare
Source updated2025-07-16

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

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