Public recall detail

VITROS® XT Chemistry Product ALB-TP Slides

2024-07-25

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Recall Safety notice
Quick summary

Quick summary: VITROS® XT Chemistry Product ALB-TP Slides. Date: 2024-07-25.

Recommended action

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

Recall details

Quick summary: VITROS® XT Chemistry Product ALB-TP Slides. Date: 2024-07-25.

Official details

Affected product details

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

BrandORTHO-CLINICAL DIAGNOSTICS INC.
ProductVITROS® XT Chemistry Product ALB-TP Slides
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75871

Affected products

ProductVITROS® XT Chemistry Product ALB-TP Slides
Lot1900148359 1900179815 1700120620
Model684 4293
Serial number1900148359 1900179815 1700120620
DescriptionVITROS® XT Chemistry Product ALB-TP Slides

Issue

QuidelOrtho™ has confirmed an issue involving VITROS® XT Chemistry Products ALB-TP slides which may create dust and debris within the microslide subsystem on VITROS® XT 3400 Chemistry Systems and VITROS® XT 7600 integrated systems. Dust and debris from XT ALB-TP slides may impact VITROS® Chemistry Products Na+ slides leading to a potential increase in non-reproducible, positively, or negatively biased Na+ results. Recall start date: July 12, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesOrtho-Clinical Diagnostics Inc. 100 Indigo Creek Drive, Rochester, New York, United States, 14626
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75871
Background{}
CompaniesOrtho-Clinical Diagnostics Inc. 100 Indigo Creek Drive, Rochester, New York, United States, 14626
AudiencesHealthcare
Source updated2024-07-25

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

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