Public recall detail

ORTHO VISION Analyzer

2024-11-22

medium
Recall Safety notice
Quick summary

Quick summary: ORTHO VISION Analyzer. Date: 2024-11-22.

Recommended action

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

Recall details

Quick summary: ORTHO VISION Analyzer. Date: 2024-11-22.

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.
ProductORTHO VISION Analyzer
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76567

Affected products

ProductORTHO VISION Max Analyzer
LotMore than 10 numbers, contact manufacturer.
Model6904576
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionORTHO VISION Max Analyzer
ProductORTHO VISION Analyzer
LotMore than 10 numbers, contact manufacturer.
Model6904577
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionORTHO VISION Analyzer

Issue

During an internal investigation Quidelortho™ identified a potential for a false positive test result due to carryover of ORTHO Sera Anti-D (DVI) on vision analyzers. Recall Start Date: November 8, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Haematology
CompaniesOrtho-Clinical Diagnostics Inc. 1001 Us Hwy 202, Raritan, New Jersey, United States, 08869
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76567
Background{}
CompaniesOrtho-Clinical Diagnostics Inc. 1001 Us Hwy 202, Raritan, New Jersey, United States, 08869
AudiencesHealthcare
Source updated2024-11-22

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

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