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Vitros® immunodiagnostic products
Official notice
11 Apr 2022
Last checked
11 Apr 2022
An official Health Canada notice concerns Vitros® immunodiagnostic products. 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 Published 2022-04-11.
What to do now
Contact the manufacturer if you require additional information.
Recall number
64064
Official notice
2022-04-11
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Ortho-clinical Diagnostics, Vitros® Immunodiagnostic.
Source & status
Source & status
Source
Tier
Category
Classification
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Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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