The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur, and test results are generated for each analyte independently of the other analyte. The ALB test is a multilayered, analytical element coated on a polyester support. For the albumin measurement, a drop of patient sample is deposited on the slide and

The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB-TP Slides may shed dust and debris as they travel through the MicroSlide Subsystem of the VITROS XT 3400 or VITROS XT 7600 analyzer. This dust and debris may then settle onto VITROS Na+ (Sodium) Slides as they are processed through the same MicroSlide Subsystem, potentially resulting in an increase in non-reproducible, positively, or negatively biased Na+ results. The level of bias will depend on where the dust and debris settle on the Na+ MicroSlide and may impact Na+ measurements to varying degrees inside and outside of the measuring range depending on the amount of contamination. All of which could vary from no/low bias with no patient harm, to extreme bias (falsely elevated or reduced results) potentially resulting in incorrect diagnosis; treatment; and/or a serious patient health hazard (for example, hypernatremia or hyponatremia). This issue may also potentially generate error codes preventing the analyzer from processing the MicroSlide Assays and cause delay of the patient results. All current and expired VITROS XT Chemistry Products ALB-TP slides are affected by this issue.

Official notice