Every recall we track for Ortho-Clinical Diagnostics, Inc. — 90 in all — plus the complaints and injury reports the public filed about them.
Ortho-Clinical recalls LAC Slides with coating 0130+ due to increased calibration failures causing delayed lab results. Affected units may impact patient care; check catalog number 8433880 and lot numbers for details.
Ortho-Clinical recalls VITROS LAC Slides with coating 0130+ due to increased calibration failures causing delayed lab results and potential patient management impacts. Affected units include specific lot numbers and expiration dates.
Ortho-Clinical recalls VITROS Ca Slides (Gen 67+) for increased calibration failures on XT 3400/7600 systems, risking delayed calcium test results and potential patient emergencies.
Ortho-Clinical recalls VITROS OP Reagent Gen 15 (model 680 1997) due to potential lower quality control results, risking delayed patient testing. Affected units have specific lot numbers and expiration dates.
Ortho-Clinical recalls VITROS CHE Slides (Japan) with catalog numbers 684 4074 and 684 4138 due to potential QC drift causing inaccurate test results. Affected units may need repeat testing or patient results could be erroneous.
Ortho-Clinical recalls VITROS CHE Slides (catalogs 191 4605 and 800 4707) due to potential inaccurate test results from QC drift when used 2-7 days after reconstitution.
Ortho-Clinical recalls VITROS Performance Verifier II units that may cause inaccurate lab results if used beyond 7 days after reconstitution.
Ortho-Clinical recalls VITROS Performance Verifier I models with potential inaccurate QC results due to quality control drift when used with specific enzyme slides. Affected lots may cause delayed patient results or erroneous test results.
Ortho-Clinical recalls VITROS 5600 Integrated Systems with model numbers 6802413 and 6802915 due to software error that may show expired reagents when none are expired, risking inaccurate test results.
Ortho-Clinical recalls VITROS 4600 Chemistry Systems with software versions 3.2 to 3.8.3 due to potential erroneous test results from expired reagent packs.
Ortho-Clinical recalls VITROS XT 7600 Integrated Systems with software versions 3.2 to 3.8.3 due to false expired reagent warnings that can cause inaccurate test results.
Ortho-Clinical recalls VITROS CRP Slides with incorrect generation code (GEN 88 instead of GEN 83) that could lead to test errors. Affected units have specific lot numbers and catalog codes.
Ortho-Clinical Diagnostics recalls Solana Bordetella kit (model M308) due to potential false positives in Bordetella parapertussis tests. Affected lots have expiration dates through 2027.
Ortho-Clinical Diagnostics recalls VITROS 3600 systems with software version 3.8.0 that may not detect expired reagent packs, risking incorrect test results.
Ortho-Clinical Diagnostics recalls VITROS 5600 Integrated Systems with software version 3.8.0 or higher. This version may not alert users when reagent packs expire, risking incorrect test results.
Ortho-Clinical Diagnostics recalls VITROS XT 7600 Integrated Systems with software version 3.8.0 or higher that may not alert users when reagent packs expire, risking incorrect test results.
Ortho-Clinical recalls VITROS XT ALB-TP Slides due to dust shedding that may cause inaccurate sodium test results, risking incorrect diagnoses and treatment. All current and expired slides are affected.
Ortho-Clinical recalls VITROS Folate Reagent Pack 1/2 due to fibrinogen precipitation causing delayed test results. Affected lots include 3380-3480.
Ortho-Clinical recalls VITROS Chemistry Diluent Pack 3 (Lot 01-1645) that may cause inaccurate test results when used with CRP Slides. Affected units include specific model and lot numbers.
Ortho-Clinical recalls VITROS Calibrator Kit 29- In-Vitor with incorrect expiration date (24-Jul-2024) that may cause inaccurate test results if not updated with Assay Data Disk.
Ortho-Clinical recalls VITROS Vitamin B12 Range Verifier Lot 1200 RV Level 2 due to potential range verification failure. No patient results affected; no action needed for most users.
Ortho-Clinical recalls VITROS Anti-HBs Calibrators due to potential for positively biased results over shelf life. Affected lots manufactured between October 2023 and December 2023.
Ortho-Clinical recalls VITROS XT 3400 Chemistry System software versions 3.8.0 and 3.8.1 due to a defect that may cause incorrect patient test results. Affected units include specific serial numbers and catalog numbers.
Ortho-Clinical recalls VITROS 3600 Immunodiagnostic Systems with specific software versions due to a defect that may cause incorrect patient test results. Affected units include catalog numbers 6802783 and 6802914.
Ortho-Clinical recalls VITROS 4600 Chemistry Systems with software version 3.8.1 that may report incorrect patient test results due to a software defect.
Ortho-Clinical Diagnostics recalls VITROS 5600 Integrated Systems with specific software versions due to a defect that may cause QC results to be accepted incorrectly, potentially leading to erroneous patient test results.
Ortho-Clinical recalls VITROS 4600 Chemistry Systems with specific software versions due to a defect that may cause incorrect patient test results. Affected units include catalog numbers 6802445 and 6900440 with serial numbers listed.
Ortho-Clinical recalls VITROS 3600 Immunodiagnostic Systems with specific software versions due to a defect that may cause incorrect patient test results. Affected units include catalog numbers 6802783 and 6802914.
Ortho-Clinical recalls VITROS XT 7600 Integrated System software versions 3.8.0 and 3.8.1 due to a defect that may cause QC results to be accepted incorrectly, potentially leading to erroneous patient test results.
Ortho-Clinical recalls VITROS XT 3400 Chemistry System software version 3.8.1 due to potential erroneous patient results from QC baseline statistics not updating correctly.
Ortho-Clinical recalls VITROS XT 7600 Integrated System software version 3.8.1 due to QC baseline statistics not updating correctly, potentially causing inaccurate patient test results.
Ortho-Clinical recalls VITROS 5600 Integrated Systems with specific software versions due to a defect that may cause incorrect patient test results. Affected units include regular and refurbished models with listed serial numbers.
Ortho-Clinical recalls VITROS 3600 Immunodiagnostic Systems (new and refurbished) due to potential aspiration during sample processing, which may cause incorrect test results. Affected units have specific serial numbers and UDI/DI codes.
Ortho-Clinical recalls VITROS XT7600 Integrated Systems due to potential aspiration during sample processing, which may cause inaccurate test results. Affected units have specific serial numbers.
Ortho-Clinical recalls VITROS 5600 Integrated Systems (new and refurbished) due to potential aspiration during sample processing, which may cause incorrect test results. Affected units have specific serial numbers and UDI/DI codes.
Ortho-Clinical recalls VITROS Anti-HBs Quantitative Reagent Packs (Catalog 6801925) due to potential calibration failures and false elevated results in lab tests. Affected lots include 8931-8990.
Ortho-Clinical is recalling QMS Tacrolimus Calibrators (Lot 74859619, exp. May 2024) due to improper storage that may cause inaccurate test results. Affected units could delay critical testing.
Ortho-Clinical recalls VITROS ECO2 Slides with potential for inaccurate CO2 test results. Affected lots may cause overdiagnosis of acidosis or alkalosis, leading to unnecessary treatments. Check product codes and lot numbers for affected items.
Ortho-Clinical recalls VITROS 3600 systems with software version 3.8.0 due to potential delays in critical test results. Affected units may require manual system updates to prevent treatment delays.
Ortho-Clinical Diagnostics recalls VITROS 5600 Integrated System software version 3.8.0 due to potential delays in critical test results from system freezes and disconnections.
Ortho-Clinical recalls VITROS XT 7600 Integrated System with Software Version 3.8.0 due to potential delays in critical test results. Affected units may experience screen freezes or printer disconnections, requiring system shutdowns to recover.
Ortho-Clinical recalls VITROS 4600 Chemistry System software version 3.8.0 due to potential delays in critical test results. Affected units may experience screen freezes or printer disconnections, risking treatment delays for patients needing urgent care.
Ortho-Clinical recalls VITROS XT 3400 Chemistry System with software version 3.8.0 due to potential delays in critical test results. Affected units may experience screen freezes or printer disconnections, risking treatment delays for patients needing urgent care.
Ortho-Clinical Diagnostics recalls VITROS Lipase Slides with potential for false low or high lipase results, risking missed pancreatitis diagnosis. Affected product codes include 1668409 and 8297749.
Ortho-Clinical recalls VITROS 5,1 chemistry system parts from April 2022 to December 2022 due to potential false test results for Gentamicin and Valproic Acid. Affected units may need replacement to prevent inaccurate patient results.
Ortho-Clinical recalls VITROS XT TBIL-ALKP Slides that may give false low liver values, risking missed liver disease diagnosis. Affected units have specific product codes and expiry dates.
Ortho-Clinical Diagnostics recalls VITROS XT ALKP Slides that may give false low liver disease results. Affected units have specific product codes and expiry dates. Stop using if you have these slides to avoid missed diagnoses.
Ortho-Clinical recalls VITROS NT-proBNP II Range Verifiers that may not meet stability requirements after their expiration date, risking inaccurate test results.
Ortho-Clinical recalls VITROS HbA1c Reagent Kits due to potential for both positive and negative HbA1c results, which could lead to misdiagnosis of diabetes. Affected lots listed in the recall notice.
Ortho-Clinical recalls VITROS Calibrator Kit 11 VANC Reagent Generation 50 with affected Assay Data Disk for delayed testing results. Fix by updating to newer software versions.
Ortho-Clinical recalls refurbished VITROS 5600 systems where microtip pack caps may not seal properly, leading to delayed test results. Affected units have specific serial numbers.
Ortho-Clinical recalls VITROS XT 7600 Integrated Systems that may cause delayed test results if MicroTip Pack caps aren't properly removed or replaced.
Ortho-Clinical recalls VITROS 5600 systems where microtip pack caps may not seal properly, causing delayed test results. Affected units have serial numbers J56000143-J56004477.
Ortho-Clinical recalls VITROS SARS-CoV-2 antibody calibrators with incorrect calibrator levels that may delay patient test results. Affected products include specific data release versions and lot numbers.
Ortho-Clinical recalls VITROS iPTH reagent packs with negative bias in test results. Affected lots may cause inaccurate parathyroid hormone measurements. Contact for remedy details.
Ortho-Clinical recalls VITROS Chemistry Calibrator Kit 9 (GEN 22) due to calibration errors causing delayed test results. Affected units include specific slide generations and lots.
Ortho-Clinical recalls VITROS XT 3400 Chemistry Systems with version 3.7.2 or older. These systems may report inaccurate test results due to electrical current shifts in the LED.
Ortho-Clinical recalls VITROS XT 7600 systems with software version 3.7.2 or older. These systems may report inaccurate test results due to electrical current shifts in the LED. Affected units have product code 6844461.
Ortho-Clinical recalls SARS-CoV-2 IgG Quantitative Reagent Packs due to incorrect on-analyzer stability time in instructions. This affects lab use on VITROS systems. No action needed per recall.
