Manufacturer
63 recalls in our database name Ortho-Clinical Diagnostics, Inc. as the manufacturing or recalling firm.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Pending LLM rewrite. Source: FDA_DEVICE Z-2560-2025.
Pending LLM rewrite. Source: FDA_DEVICE Z-2559-2025.
Pending LLM rewrite. Source: FDA_DEVICE Z-2335-2025.
Pending LLM rewrite. Source: FDA_DEVICE Z-2120-2025.
Pending LLM rewrite. Source: FDA_DEVICE Z-2122-2025.
Pending LLM rewrite. Source: FDA_DEVICE Z-2121-2025.
Pending LLM rewrite. Source: FDA_DEVICE Z-2123-2025.
Pending LLM rewrite. Source: FDA_DEVICE Z-2073-2025.
Ortho-Clinical Diagnostics is recalling VITROS XT 7600 Integrated System analyzers due to a software anomaly that can report test results as expired when reagent shelf expiration dates are omitted during manual loading, potentially causing erroneous or delayed test results.
Pending LLM rewrite. Source: FDA_DEVICE Z-2040-2025.
Ortho-Clinical Diagnostics is recalling the VITROS 5600 Integrated System due to a software anomaly that can report test results using expired reagents even when the use-expired-reagents setting is disabled, potentially causing erroneous or delayed test results.
Ortho-Clinical Diagnostics is recalling the Solana Bordetella Complete Assay Kit (Model M308) because it may produce false positive results for Bordetella parapertussis at a rate of up to 16.7%.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CRP Slides because the product carton, foil wrapper, and cartridge label were incorrectly marked with "GEN 88" instead of the correct "GEN 83" designation.
The VITROS 5600 Integrated System's software (version 3.8.0 and higher) may fail to notify users when Signal Reagent Packs expire. This could result in use of expired reagents, causing no results or erroneous results from tests.
VITROS XT 7600 Integrated System software may not warn users when Signal Reagent Packs expire, risking inaccurate or missing test results.
The VITROS 3600 Immunodiagnostic System may not properly alert users when Signal Reagent Packs expire, risking use of expired products and potentially inaccurate test results. Affected systems worldwide should be checked for this software issue.
Ortho-Clinical Diagnostics is recalling 7,717 units of VITROS CRP diagnostic slides that may produce falsely low results for high C-reactive protein samples, risking missed diagnosis of infection or inflammation.
Ortho-Clinical Diagnostics is recalling 88,253 units of VITROS XT Chemistry ALB-TP Slides because they shed dust and debris during normal operation, potentially contaminating sodium test results and causing misdiagnosis.
Ortho-Clinical Diagnostics is recalling VITROS Folate Reagent Pack due to fibrinogen precipitation causing delayed test results. The recall affects 18,467 units distributed worldwide.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry FS Diluent Pack 3, Lot 01-1645, because it may produce negatively biased results when used with CRP slides, potentially affecting patient diagnosis and care.
Ortho-Clinical Diagnostics is recalling a calibrator kit with an incorrect expiration date that could bias lab results if used past its true expiration date.
Ortho-Clinical Diagnostics is recalling VITROS Anti HBs Calibrators due to potential for positively biased results caused by signal reduction over shelf life. Approximately 481 units were distributed worldwide.
Ortho-Clinical Diagnostics is recalling VITROS Vitamin B12 Range Verifier Lot 1200 because the product may fail to verify required calibration range. The failure is detectable during use and does not affect actual patient test results.
Ortho-Clinical Diagnostics is recalling VITROS 5600 diagnostic systems (software versions 3.8.0 or 3.8.1) due to a defect that prevents quality control alerts from displaying, potentially allowing erroneous patient test results to be reported.
The VITROS 3600 Immunodiagnostic System is being recalled due to potential aspiration of sample containers during laboratory processing, which may result in erroneous test results.