Bromcresol Green Dye-binding, Albumin

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 plasti

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.

Roche Diagnostics cobas Integra Albumin Gen.2

Due to low Quality Control recovery and invalid Calibration.

VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21

Observed particulate matter in some reagent cartridges.

Roche Diagnostics ALBT2, Tina-quant Albumin Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04469658190.

Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

Albumin Gen.2, Catalog 05166861190

Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.