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Ortho Cinical Diagnostics (quidelortho) has determined that some lots from coating 3598 of Vitros Eco2 Slides include carts which may contain consecutive slides that may not function as intended. These affected Vitros Eco2 slides (potentially…

Per the VITROS CKMB slides instructions for use (IFU) "principles of the procedure" section, the spread layer of the CKMB slide contains goat antihuman CK-mm antibodies, which inhibit CK-mm (muscle) activity and ~50% of the CK-mb (heart) activity. The…

After the launch of software version (v) 3.8.0, Ortho Clinical Diagnostics (QuidelOrtho) began post-release monitoring of the rollout of v3.8.0. this monitoring has led QuidelOrtho to confirm that if v3.8.0 has been installed on the VITROS® systems…

Certain proboscis/piston assembly (or assemblies) manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an out-of-specification barrel component. This may cause Vitros® Versatips and/…

Ortho Clinical Diagnostics (QuidelOrtho™) identified a trend regarding false positive results for specific tests (listed below) processed after Ortho Sera Anti-Jkb Tests, on the ID-MTS™ buffered gel cards when tested on the Ortho Vision Analyzer. It is…

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…