Overview of recall records associated with Ortho-Clinical Diagnostics, including dates, categories and classifications where available.
Classification mix: Class II: 89, Class III: 14.
Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
Potentially Biased Results using VITROS Chemistry Products GLU Slides
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems.
Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without…
Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.
Negative bias results when using VITROS VALP Reagent, GEN 25.
The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower…
The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower…
The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower…
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
This page summarizes recall records in which the official source identifies Ortho-Clinical Diagnostics as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
