Vitros® Immunodiagnostic Products
Brand(s)
Summary
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. | 1931922 |
| Vitros® Immunodiagnostic Products Lh Reagent Pack | 1950, 1940, 1960, 1920, 1930, 1910 | 135 0198 |
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
Additional information
Details
Ortho-Clinical Diagnostics
Felindre Meadows, Bridgend
Great Britain, CF35 5PZ
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