Health product recall

Vitros® Immunodiagnostic Products

Last updated


Vitros® Immunodiagnostic Products
Medical devices - Quality issue
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Vitros® Immunodiagnostic Products Prolactin Reagent Pack

2870, 2880, 2891, 2840, 2860, 2875, 2850, 2900

184 9793

Vitros® Immunodiagnostic Products Fsh Reagent Pack

More than 10 numbers, contact manufacturer.


Vitros® Immunodiagnostic Products Lh Reagent Pack

1950, 1940, 1960, 1920, 1930, 1910

135 0198


Ortho Clinical Diagnostics has observed an increase in complaints, and confirmed observed imprecision, for low-level quality control (QC) and patient samples at the low end of the measuring (reportable) range when using Vitros FSH, LH and PROL reagent. Complaints have also been received regarding calibration failures, driven by imprecision observed with calibrator level 1.

The investigation indicates the imprecision is caused by additional signal generated during processing, resulting in falsely elevated results. This additional signal is caused by an interaction between reagent lots and some Vitros systems.

While all reagent lots have the potential for imprecision, the majority of customers are not affected as we have confirmed that not all vitros systems exhibit the issue.

Recall start date: Mar 25, 2022

Additional information

Original published date:
Alert / recall type
Health product recall
Health products - Medical devices - Chemistry

Ortho-Clinical Diagnostics

Felindre Meadows, Bridgend

Great Britain, CF35 5PZ

Published by
Health Canada
General public
Health professionals
Recall class
Type II
Identification number

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