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.
A software defect in VITROS XT 3400 Chemistry Systems prevents quality control rules from properly reporting failures in test controls. This may result in erroneous patient test results being reported.
A software defect in VITROS 4600 Chemistry Systems running software versions 3.8.0 or 3.8.1 prevents quality control rules from being flagged or reported correctly, potentially allowing erroneous patient results to be released.
Ortho-Clinical Diagnostics is recalling the VITROS XT7600 Integrated System due to potential aspiration from unintended sample containers during processing, which may result in erroneous test results. The recall affects 1,720 units distributed worldwide.
A software defect in the VITROS 3600 Immunodiagnostic System may cause quality control baseline statistics to fail to update properly, potentially resulting in erroneous patient test results.
Ortho-Clinical Diagnostics is recalling VITROS XT 7600 systems with software defects in versions 3.8.0 and 3.8.1. The defect prevents quality control rules from being properly reported, which could cause erroneous patient test results.
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.
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.
A software defect in VITROS XT 7600 diagnostic systems running version 3.8.1 causes quality control baseline statistics to fail to update properly, potentially resulting in erroneous patient laboratory results.
Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to a software defect affecting quality control baseline statistics, which may cause inaccurate patient test results.
A software defect in VITROS 3600 Immunodiagnostic Systems (versions 3.8.0 and 3.8.1) prevents quality control rules from reporting failures as expected, potentially allowing invalid test results to be reported.
Ortho-Clinical Diagnostics is recalling VITROS immunodiagnostic analyzer systems that may aspirate unintended sample containers during processing, potentially causing erroneous test results.
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products used to test for Hepatitis B antibodies due to potential calibration failures and falsely elevated test results affecting specific lot numbers.
Ortho-Clinical Diagnostics is recalling QMS Tacrolimus Calibrators Lot 74859619 due to improper storage that degrades product quality, potentially causing erroneous test results and testing delays.
Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to software issues causing screen freezes and system unresponsiveness. The problems can delay reporting of patient test results, including critical or STAT assays.
Ortho-Clinical Diagnostics recalls 216 VITROS XT 7600 laboratory systems running Software Version 3.8.0 due to software issues causing screen freezes and unresponsiveness. The defects delay test result reporting and could postpone patient treatment.
Ortho-Clinical Diagnostics is recalling the VITROS 3600 Immunodiagnostic System due to software issues causing system freezes and delayed test result reporting. The delays could affect patient care when rapid results are critical.
The VITROS 5600 laboratory analyzer is being recalled due to software issues causing screen freezes and printer disconnections that delay test result reporting, potentially affecting patient care.
Ortho-Clinical Diagnostics is recalling 51 units of the VITROS 4600 Chemistry System due to software defects causing system freezes and disconnections that could delay critical test result reporting.
Ortho-Clinical Diagnostics is recalling certain VITROS ECO2 diagnostic slides that may produce inaccurate carbon dioxide measurements, potentially leading to misdiagnosis of acid-base balance disorders.
Ortho-Clinical Diagnostics is recalling VITROS Lipase Slides due to measurement abnormalities that could result in falsely low or elevated test results. This could delay diagnosis of acute pancreatitis or cause diagnostic confusion.
Ortho-Clinical Diagnostics is recalling 9,860 Proboscis/Piston Assemblies for VITROS diagnostic systems manufactured April-December 2022 due to a manufacturing defect that may cause falsely elevated drug assay results and delayed patient test results.
Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry TBIL-ALKP Slides because they may report incorrectly low liver enzyme values, potentially leading to missed or delayed liver disease diagnoses. Approximately 52,456 units were distributed worldwide.
Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry ALKP Slides worldwide because high alkaline phosphatase samples may cause the analyzer to report falsely low results, potentially missing or delaying liver disease diagnoses.
Ortho-Clinical Diagnostics is recalling VITROS NT-proBNP II Range Verifiers Lot 0090 because the product may not meet shelf life stability specifications. Used for diagnostic system calibration verification.
Ortho-Clinical Diagnostics is recalling 132 units of VITROS Chemistry Calibrator Kit 11 with defective Assay Data Disk versions due to inability to calibrate vancomycin reagent, delaying laboratory testing.