Public recall detail

Vitros® Immunodiagnostic Products

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Recall Safety notice
Quick summary

Quick summary: Vitros® Immunodiagnostic Products.

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Recall details

Quick summary: Vitros® Immunodiagnostic Products.

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
ProductVitros® Immunodiagnostic Products
IssueMedical devices - Quality
Recall classType II
IdentificationRA-64064

Affected products

ProductVitros® Immunodiagnostic Products Prolactin Reagent Pack
Lot2870, 2880, 2891, 2840, 2860, 2875, 2850, 2900
Model184 9793
Serial number2870, 2880, 2891, 2840, 2860, 2875, 2850, 2900
DescriptionVitros® Immunodiagnostic Products Prolactin Reagent Pack
ProductVitros® Immunodiagnostic Products Fsh Reagent Pack
LotMore than 10 numbers, contact manufacturer.
Model1931922
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVitros® Immunodiagnostic Products Fsh Reagent Pack
ProductVitros® Immunodiagnostic Products Lh Reagent Pack
Lot1950, 1940, 1960, 1920, 1930, 1910
Model135 0198
Serial number1950, 1940, 1960, 1920, 1930, 1910
DescriptionVitros® Immunodiagnostic Products Lh Reagent Pack

Issue

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Health professionals Hospitals
CategoryHealth products - Medical devices - Chemistry
CompaniesOrtho-Clinical Diagnostics Felindre Meadows, Bridgend Great Britain, CF35 5PZ
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-64064
Background{}
CompaniesOrtho-Clinical Diagnostics Felindre Meadows, Bridgend Great Britain, CF35 5PZ
AudiencesGeneral public Health professionals Hospitals
Source updated2022-04-11

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

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