Health product recall

Vitros® Systems

Last updated


Vitros® Systems
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 


Affected products

Affected products

Lot or serial number

Model or catalogue number

Vitros 5600 Integrated System

More than 10 numbers, contact manufacturer.

680 2413
680 2915

Vitros Xt 7600 Integrated System

More than 10 numbers, contact manufacturer.

684 4461

Vitros 3600 Immunodiagnostic System - Instrument

More than 10 numbers, contact manufacturer.

680 2914
680 2783


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

Additional information

Original published date:
Alert / recall type
Health product recall
Health products - Medical devices - Chemistry
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive, Rochester, New York, United States, 14626
Published by
Health Canada
Recall class
Type II
Identification number

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