Every recall we track for Ortho-Clinical Diagnostics — 78 in all — plus the complaints and injury reports the public filed about them.
Ortho-Clinical Diagnostics recalls VITROS Performance Verifier II devices due to risk of incorrect test results for sodium and carbon dioxide. Affected units may cause patient testing delays or inaccurate results.
Ortho-Clinical Diagnostics recalls VITROS Performance Verifier I devices with mismatched diluent lots that may cause incorrect test results, leading to potential patient safety risks.
Ortho-Clinical Diagnostics recalls VITROS Troponin I ES Calibrators that may produce false negative results due to incorrect wells. Affected units have specific product codes and expiration dates.
Ortho-Clinical Diagnostics recalls VITROS Troponin I ES Reagent Packs that could produce false negative results due to incorrect wells. Affected lots were sold until June 2023.
Ortho-Clinical Diagnostics recalls VITROS Chemistry Products Calibrator Kit 20 for potential biased lab results in transferrin, C3, C4, IgA, IgG and IgM tests. Affected units may show inaccurate results.
Ortho Clinical Diagnostics recalls VITROS XT3400 Chemistry System (product code 6844458) due to potential erroneous test results from mispositioned MicroSlides in Slot 18 of the CM rotor. Affected units have serial numbers J34500122 to J34500231.
Ortho Clinical Diagnostics recalls VITROS XT7600 Integrated System with serial numbers J76000050-J76000566 due to potential erroneous test results from mispositioned MicroSlides in Slot 18 of the CM rotor.
Ortho Clinical Diagnostics recalls VITROS Anti-SARS-CoV-2 Total Reagent (COV2TOT) due to potential false negatives or delayed results from swapped bottles. Affected lots 0010-0037.
Ortho Clinical Diagnostics recalls VITROS Anti-SARS-CoV-2 IgG Reagent Packs due to potential false negatives or delayed results from swapped bottles. Affected lots 0010-0013.
Ortho-Clinical Diagnostics recalls VITROS Chemistry BuBc Slides due to etrombopag interference. Affected products measure bilirubin; check UDI codes for details.
Ortho-Clinical Diagnostics recalls VITROS TBIL Slides due to potential etrombopag interference affecting bilirubin test accuracy. All current, future, and past lots are affected.
Ortho-Clinical Diagnostics recalls VITROS XT TBIL-ALKP Slides due to etrombopag interference in TBIL tests. This affects in vitro diagnostic use only. No remedy specified in official notice.
Ortho Clinical Diagnostics recalls refurbished VITROS 3600 systems with serial numbers starting 36000192-36001042 due to potential parameter reset affecting test accuracy.
Ortho Clinical Diagnostics recalls VITROS 5600 Integrated System Software Versions 3.3.3 and below due to potential reset of assay parameters. Affected units have serial numbers J56000114-J56001879.
Ortho Clinical Diagnostics recalls VITROS XT 7600 software versions 3.5.1 and below due to potential reset of assay parameters. Affected units have serial numbers J76000111-J76000525.
Ortho Clinical Diagnostics recalls VITROS 5600 Integrated System software versions 3.3.3 and below due to potential reset of assay parameters. Affected units may require software updates to prevent inaccurate test results.
Ortho Clinical Diagnostics recalls VITROS 3600 software versions 3.3.3 and below due to potential reset of assay parameters. Affected units have serial numbers J36000109-J36001317.
Ortho-Clinical Diagnostics recalls AMYL Slides Reagent (Product Code 8112724) due to imprecision in lab test results. Affected lots may cause inaccurate amylase measurements.
Ortho-Clinical Diagnostics recalls VITROS Chemistry Product Performance Verifier II (Product Code 8067324) due to imprecise control fluid measurements affecting lab test accuracy. Affected units may show inconsistent results with expected standards.
Ortho-Clinical Diagnostics recalls AMYL Slides Reagent (Product Code 1202670) due to imprecision in lab test results. Affected lots may cause inaccurate amylase measurements.
Ortho-Clinical Diagnostics recalls VITROS Chemistry Product Performance Verifier I due to imprecise control fluid measurements affecting lab test accuracy. Affected units may show inconsistent results with expected standards.
Ortho-Clinical Diagnostics recalls VITROS CKMB Slides (Product Code 805 8232-300) due to false plasma test results from Spanish/Swedish IFU instructions. Affected units expire after July 20, 2018.
Ortho-Clinical Diagnostics recalls VITROS CKMB Slides (Product Code 8001133-90) due to false plasma test results in Spanish/Swedish language versions of instructions. Affected units expire after July 20, 2018.
Ortho Clinical Diagnostics recalls VITROS TT4 Reagent Packs with Product Code 8744468 due to increased unsuccessful calibrations. Affected units may need replacement to ensure accurate test results.
Ortho-Clinical Diagnostics recalls VITROS chemistry Cl- Slides (Catalog No. 6844471) due to intermittent slide dispense issues from anti-backup platen failure in some cartridges.
Ortho-Clinical Diagnostics recalls VITROS chemistry K+ Slides (Catalog No. 8157596) due to intermittent slide dispense issues from anti-backup platen failure in some cartridges.
Ortho-Clinical Diagnostics recalls VITROS chemistry Cl- Slides (Catalog No. 8445207) due to intermittent slide dispense issues from anti-backup platen failure. Affected units may require replacement.
Ortho Clinical Diagnostics recalls VITROS Chemistry Products Calibrator Kit 32 due to potential unsuccessful calibration from software anomalies in the VITROS system. Affected units include specific product codes and assay data disks.
Ortho Clinical Diagnostics recalls VITROS 5600 Integrated System due to potential unsuccessful calibration from software anomalies in version 3.3.2 or higher. Affected units may require software updates to ensure accurate lab results.
Ortho Clinical Diagnostics recalls VITROS 350 Chemistry System due to potential unsuccessful calibration from software anomaly. Affected units have specific software version 9.7.
Ortho Clinical Diagnostics recalls VITROS 4600 Chemistry System due to software anomaly potentially causing unsuccessful calibration. Affected units have software version 3.3.2 or higher.
Ortho Clinical Diagnostics recalls VITROS 4600 Chemistry System due to software anomaly that could lead to unsuccessful calibration. Affected units have software version 3.3.2 or higher.
Ortho Clinical Diagnostics recalls VITROS 25:0AT chemistry analyzers with software version 9.7 due to potential calibration failures. Affected units may not provide accurate test results.
Ortho Clinical Diagnostics recalls VITROS : 5,1 FS Chemistry System due to potential unsuccessful calibration from software anomalies in version 3.1 or above. Affected units may need software update.
Ortho Clinical Diagnostics recalls VITROS Calibrator Kit 32 due to potential unsuccessful calibration from software anomalies. Affected units may need repair or replacement.
Ortho Clinical Diagnostics recalls VITROS : Potential unsuccessful calibration due to software anomaly in version 3.1+.
Ortho Clinical Diagnostics recalls VITROS 250 Chemistry System due to software anomaly potentially causing unsuccessful calibration. Affected units have specific software version 9.7.
Ortho Clinical Diagnostics recalls VITROS 250 Chemistry System due to potential unsuccessful calibration from software anomaly in version 9.7. Affected units may need software update.
Ortho Clinical Diagnostics recalls VITROS 5600 clinical chemistry analyzers with software version 3.3.2 or higher due to potential calibration issues. Affected units may produce inaccurate test results.
Ortho-Clinical Diagnostics recalls VITROS Chemistry Glucose Slides (Product Code 1707801) due to potential for inaccurate glucose test results. Affected units were sold with specific lot numbers and expiration dates.
Ortho-Clinical Diagnostics recalls VITROS 250AT Chemistry System (Product Code 1758143) due to potential negative drift in Creatine Kinase (CK) test results. Affected units may produce inaccurate test results.
Ortho-Clinical Diagnostics recalls refurbished VITROS 250 Chemistry System (Product Code 6801759) due to potential negative drift in Creatine Kinase (CK) test results. Affected units may produce inaccurate blood test results.
Ortho-Clinical Diagnostics recalls VITROS 250 Chemistry System (Product Code 8132086) due to potential negative drift in Creatine Kinase (CK) test results. Affected units may produce inaccurate test results.
Ortho-Clinical Diagnostics recalls VITROS 350 Chemistry System (Product Code 6802153) due to potential negative drift in Creatine Kinase (CK) test results when used with VITROS 250 and 350 systems. Affected units may produce inaccurate test results.
Ortho-Clinical Diagnostics recalls VITROS XT 7600 Integrated System with V3.4 or 3.4.1 software (product code 6844461) due to potential for incorrect test results. Affected units have serial numbers 76000108 through current.
Ortho-Clinical Diagnostics recalls VITROS XT 7600 Integrated System (Product Code 6844461) due to software error that may cause incorrect test results without error alerts. Affected units run software versions 3.4 or 3.4.1.
Ortho-Clinical Diagnostics recalls refurbished VITROS 3600 systems with software V3.3.2 or below (product code 6802914) due to possible luminometer malfunction causing inability to process microwell assays.
Ortho-Clinical Diagnostics recalls VITROS XT 7600 Integrated System software versions 3.4.1 and below due to potential luminometer malfunction causing inability to process MicroWell assays.
Ortho-Clinical Diagnostics recalls refurbished VITROS ECi Immunodiagnostic System (Product Code 6801059) due to potential luminometer malfunction causing inability to process microwell assays on VITROS systems.
Ortho-Clinical Diagnostics recalls VITROS 5600 systems with refurbished software V3.3.2 or below due to luminometer malfunction that may prevent processing microwell assays. Affected units have specific serial numbers and were serviced with a luminometer replacement.
Ortho-Clinical Diagnostics recalls VITROS 5600 systems with software V3.3.2 or below (product code 6802413) due to possible luminometer malfunction causing inability to process microwell assays. Affected units include serial numbers 56003270 and above with UDI 10758750002740.
Ortho-Clinical Diagnostics recalls VITROS ECi/ECiQ Immunodiagnostic Systems with serial numbers 30005946-30006005 due to potential luminometer malfunction causing inability to process microwell assays.
Ortho-Clinical Diagnostics recalls VITROS 3600 software versions 3.3.2 and below due to potential luminometer malfunction causing inability to process microwell assays. Affected units include specific product codes and serial numbers.
Ortho-Clinical Diagnostics recalls VITROS Na+ Slides (Catalog 8379034) due to possible inaccurate sodium test results. Affected lots may produce biased patient and quality control results.
Ortho-Clinical Diagnostics recalls VITROS VALP Reagent Pack (catalog #6801710) due to negative bias results in valproic acid testing. Affected lots from 2017-2019 may cause inaccurate test results.
Ortho-Clinical Diagnostics recalls VITROS HBeAg Reagent (Cat. No 6801819) due to potential biased results at lower biotin concentrations than specified in instructions. This affects lab tests for hepatitis B e antigen in blood samples.
Ortho-Clinical Diagnostics is recalling VITROS Anti-HBe Reagent Pack (Cat No. 6801816) due to potential biased results at lower biotin concentrations than specified in instructions. This affects laboratory testing for hepatitis B.
Ortho-Clinical Diagnostics recalls VITROS NT-proBNP Reagent (Cat No. 6802156) due to potential biased results at low biotin concentrations. This affects in vitro diagnostic testing for heart failure and cardiac risk assessment.
Ortho-Clinical Diagnostics recalls VITROS 5600 Integrated System versions 3.3.1 and below due to software anomaly that may incorrectly extend reagent stability time, potentially affecting test accuracy.
Ortho-Clinical Diagnostics recalls VITROS 4600 Chemistry System versions 3.3.1 and below due to software anomaly that may incorrectly extend reagent stability time.
