Public recall detail

Vitros® Chemistry Products System - DGXN Slides (Digoxin)

2024-12-19

medium
Recall Safety notice
Quick summary

Quick summary: Vitros® Chemistry Products System - DGXN Slides (Digoxin). Date: 2024-12-19.

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® Chemistry Products System - DGXN Slides (Digoxin). Date: 2024-12-19.

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® Chemistry Products System - DGXN Slides (Digoxin)
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-76723

Affected products

ProductVitros® Chemistry Products System - DGXN Slides (Digoxin)
LotMore than 10 numbers, contact manufacturer.
Model834 3386
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVitros® Chemistry Products System - DGXN Slides (Digoxin)

Issue

QuidelOrtho has confirmed an issue involving Vitros® Chemistry Products DGXN Slides which may generate negatively biased results due to hemoglobin interference at a concentration lower than what is currently listed in the instructions for use (ifu) at 300 mg/dl (3 g/l). Recall start date: December 10, 2023.

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-76723
Background{}
CompaniesOrtho-Clinical Diagnostics Inc. 100 Indigo Creek Drive, Rochester, New York, United States, 14626
AudiencesHealthcare
Source updated2024-12-19

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

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