Public recall detail

Vitros® Systems

2024-03-07

medium
Recall Safety notice
Quick summary

Quick summary: Vitros® Systems. Date: 2024-03-07.

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® Systems. Date: 2024-03-07.

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® Systems
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75187

Affected products

ProductVitros 5600 Integrated System
LotMore than 10 numbers, contact manufacturer.
Model680 2413 680 2915
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVitros 5600 Integrated System
ProductVitros Xt 7600 Integrated System
LotMore than 10 numbers, contact manufacturer.
Model684 4461
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVitros Xt 7600 Integrated System
ProductVitros 3600 Immunodiagnostic System - Instrument
LotMore than 10 numbers, contact manufacturer.
Model680 2914 680 2783
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVitros 3600 Immunodiagnostic System - Instrument

Issue

Some serial numbers of the Vitros® systems as listed above may experience an anomaly involving the sampling center, which may have been manufactured using a sub-optimal hardware part. Quidelortho confirmed a complaint where the sampling center mechanism unintentionally disengaged from the universal sample tray (tray), resulting in the misalignment of the intended sample container to be aspirated. From our investigation of this single occurrence, Quidelortho determined that if this disengagement and misalignment occurs, it may cause one or multiple patient samples to be aspirated from an unintended sample container within the same tray and report the results using the incorrect patient samples. Based on the investigation, Quidelortho estimates the likelihood of this occurrence to be approximately 0.00000035% (or about 1 in 2.88 million tests.) Recall start date: January 26, 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-75187
Background{}
CompaniesOrtho-Clinical Diagnostics Inc. 100 Indigo Creek Drive, Rochester, New York, United States, 14626
AudiencesHealthcare
Source updated2024-03-07

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

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