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The Vitros Chemistry Products Calibrator Kit 20 is used to calibrate Microtip assays C3, C4, IgM, IgA, IgG, and transferrin. Vitros Calibrator Kit 20 contains five calibrator levels. Although lot 2022 met all initial release criteria, vial to vial…

During Ortho's internal release testing of lot 34-1345, an issue was confirmed up to 6% of reagent packs may generate the biased results. Subsequent testing also confirmed atypical drift on results obtained from affected reagent packs. As the issues were…

Ortho's investigation discovered that the self-service customer procedures guide, both onboard and offboard, contains 2 errors related to the probe installation/removal process (chapter 4). 1. The self-service customer procedure guide contains a note…

Ortho determined that data release versions (DRV) 6194 through 6200 of the calibration diskette contain an erroneous value in the calibration mathematics for gen 22 of Vitros phyt slides. This erroneous value prevents Vitros 250/350 chemistry systems…

During normal operation of the ortho vision analyzer, the camera imaging subsystem (CIMS) interfaces with a hardware camera to request and retrieve camera images for column grading and results interpretation. The camera software uses a first-in, first-…

On the Ortho Optix Reader, when reviewing the results, the user can edit a grade and/or analysis of the results. • When performing this action, the user may also choose to "cancel" the edit. •Wwhen cancelling the edit, the user is informed that the "…

Ortho Clinical Diagnostics (Ortho) became aware of an anomaly that affects Vitros Xt 3400 and Vitros Xt 7600 systems. These systems utilize a digital imaging reflectometer and led light source to generate Vitros microslide assay results. Ortho's on-going…

During an internal investigation, Ortho identified that the Anti-Lea (Anti-Le1) lot LAB170A was demonstrating weak to no reactivity with Lea positive cells. The results of the investigation demonstrated that lot LAB170A was more than two dilutions lower…

Ortho Clinical Diagnostics received complaints in which customers obtained unexpected results on their Ortho Vision Analyzer. upon further investigation, Ortho confirmed that incorrect utilization of the "assign to position" feature by physically placing…

Ortho Clinical Diagnostics received a complaint regarding an incorrectly displayed passing QC status for a test (see example in table below), without the site having processed the multiple QC kits configured for the test. Ortho confirmed that any test…

Ortho received complaints and confirmed that there is potential for deformed Versatip with lot 1039734. this deformity can lead to an improper seal of the tip on the Proboscis. an improperly sealed tip may cause a condition code to post…

The affected vitros CKMB slides coating does not adequately inhibit CK-mm up to a total CK more than 1000 u/L. Therefore, samples with a total CK value less than 1000 u/L may exhibit falsely elevated vitros CKMB slides results. Recall start date: Nov…

Ortho-clinical diagnostics confirmed that when the ORTHO OPTIX Reader software is determining the card lot number from the MTS card barcode, the software does not decode the appropriate numbers of the barcode. Recall start date: 2021-11-19