Medical device manufacturer, Ortho Clinical Diagnostics, has issued a medical device safety alert concerning its VITROS Chemistry Products DAT Performance Verifiers [Product Code (Lot Number): 6802327 (H5616); 6802328 (J5617); 6802329 (K5618); 6802330 (L5619); 6802331 (M5620)].
This notification provides information regarding lower than expected Quality Control (QC) results obtained for VITROS BENZ Reagent using the specific lots of VITROS DAT Performance Verifier listed above.
The manufacturer performed an investigation and determined that QC results for BENZ (only) were lower than expected when using the affected lots. Data confirmed that the concentration of lormetazepam (BENZ) in the affected lots of VITROS DAT PVs has shown a decrease over time. There are reduced levels of lormetazepam when the controls were tested on a confirmatory method (i.e., gas chromatography/mass spectrometry). No other assays in the VITROS DAT Performance Verifiers are affected by this issue.
If the issue occurs, QC results for BENZ may be at or below Ortho's Range of Means as defined in the Assay Sheets. This issue may lead to an inability to verify calibration or cause failures in daily QC results.
According to the manufacturer, if the QC results using VITROS DAT Performance Verifiers are within the established ranges for each assay, it is acceptable to use the affected lots until a replacement order arrives.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 September 2017