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Vitros Immunodiagnostic Products Tsh Reagent Pack and Calibrators, Vitros 5600 Integrated System

by Ortho-Clinical Diagnostics, Inc.

510(k) K081543

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

10 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK081543 Date23 Oct 2008ClearedStatusActive

Recalls

39 recalls · 10 ongoing · FDA

    • Ongoing Z-2038-2025 FDA Class II initiated 9 May 2025 on shared 510(k) K081543

    A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.

    • Ongoing Z-1005-2025 FDA Class II initiated 19 Dec 2024 on shared 510(k) K081543

    The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.

    • Ongoing Z-1226-2024 FDA Class II initiated 26 Jan 2024 on shared 510(k) K081543

    A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

    • Ongoing Z-1231-2024 FDA Class II initiated 26 Jan 2024 on shared 510(k) K081543

    A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.

    • Ongoing Z-1221-2024 FDA Class II initiated 22 Jan 2024 on shared 510(k) K081543

    Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

    • Ongoing Z-0545-2024 FDA Class II initiated 10 Oct 2023 on shared 510(k) K081543

    During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.

    • Ongoing Z-0008-2024 FDA Class II initiated 9 Aug 2023 on shared 510(k) K081543

    Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and 19-Dec-2022 (Date code: 121922) may not perform as intended due to an out-of-specification barrel component. This may cause VITROS VersaTips and/or VITROS MicroTips to be improperly seated on the proboscis, which may result in falsely elevated Gentamicin and Valproic Acid assay results as well as an increased frequency of condition codes resulting in delayed patient results. The issue was identified by internal testing when reported instruments failed to pass release testing and were traced to the molded Proboscis part J56639 with date codes from 040722 onward.

  • 2 recalls, same reason

    • Ongoing Z-1557-2023 FDA Class II initiated 10 Mar 2023 on shared 510(k) K081543
    • Ongoing Z-1556-2023 FDA Class II initiated 10 Mar 2023 on shared 510(k) K081543

    MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS 5600 and XT 7600 Integrated Systems, results may be delayed results if a pack becomes unusable

    • Ongoing Z-0061-2019 FDA Class II initiated 12 Jul 2018

    The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.

  • 2 recalls, same reason

    • Terminated Z-2179-2019 FDA Class II initiated 8 Jul 2019 on shared 510(k) K081543
    • Terminated Z-2180-2019 FDA Class II initiated 8 Jul 2019 on shared 510(k) K081543

    Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

  • 2 recalls, same reason

    • Terminated Z-1288-2019 FDA Class II initiated 20 Feb 2019 on shared 510(k) K081543
    • Terminated Z-1287-2019 FDA Class II initiated 20 Feb 2019 on shared 510(k) K081543

    Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems

    • Terminated Z-0650-2019 FDA Class II initiated 19 Oct 2018 on shared 510(k) K081543

    Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.

  • 2 recalls, same reason

    • Terminated Z-0079-2019 FDA Class II initiated 15 Aug 2018
    • Terminated Z-0080-2019 FDA Class II initiated 15 Aug 2018

    Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.

    • Terminated Z-2344-2018 FDA Class II initiated 9 May 2018 on shared 510(k) K081543

    There is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples.

    • Terminated Z-0273-2018 FDA Class II initiated 12 Jun 2017 on shared 510(k) K081543

    The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples. The current Instructions for Use (IFU) and Assay Summary Chart state serum, heparin plasma, and citrate plasma as acceptable specimen types for use with the PHYT assay.

    • Terminated Z-1914-2016 FDA Class II initiated 6 Apr 2016 on shared 510(k) K081543

    Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results.

    • Terminated Z-1348-2016 FDA Class II initiated 16 Feb 2016 on shared 510(k) K081543

    The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated AC power cord is unplugged.

    • Terminated Z-1074-2016 FDA Class II initiated 21 Dec 2015 on shared 510(k) K081543

    Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).

    • Terminated Z-0641-2016 FDA Class II initiated 3 Nov 2015 on shared 510(k) K081543

    Software anomaly may allow VITROS Systems to sample and process assays while the fluids and reagent temperatures are not in the required temperature range for optimal processing. When this intermittent issue occurs, the VITROS Systems continue to operate and process results without notification to the User, possibly producing erroneous results.

    • Terminated Z-0202-2016 FDA Class III initiated 28 Sep 2015 on shared 510(k) K081543

    The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954.

  • 2 recalls, same reason

    • Terminated Z-1743-2015 FDA Class II initiated 6 Apr 2015 on shared 510(k) K081543
    • Terminated Z-1742-2015 FDA Class II initiated 6 Apr 2015 on shared 510(k) K081543

    Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results.

  • 3 recalls, same reason

    • Terminated Z-0968-2015 FDA Class II initiated 19 Nov 2014 on shared 510(k) K081543
    • Terminated Z-0967-2015 FDA Class II initiated 19 Nov 2014 on shared 510(k) K081543
    • Terminated Z-0969-2015 FDA Class II initiated 19 Nov 2014 on shared 510(k) K081543

    Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.

    • Terminated Z-0078-2015 FDA Class II initiated 8 Sep 2014 on shared 510(k) K081543

    Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned (i.e., hidden).

    • Terminated Z-2141-2014 FDA Class II initiated 7 Jul 2014 on shared 510(k) K081543

    Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number.

    • Terminated Z-1735-2014 FDA Class II initiated 10 Apr 2014 on shared 510(k) K081543

    Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected

    • Terminated Z-0321-2014 FDA Class II initiated 12 Jun 2013 on shared 510(k) K081543

    Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

    • Terminated Z-1948-2013 FDA Class II initiated 6 Jun 2013 on shared 510(k) K081543

    Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement.

    • Terminated Z-1649-2013 FDA Class II initiated 6 May 2013 on shared 510(k) K081543

    There is evidence that an electrical short within the systems connector has caused an accumulation of heat which has radiated back through the wiring harness causing the wires and connectors to melt.

    • Terminated Z-1108-2013 FDA Class II initiated 7 Feb 2013 on shared 510(k) K081543

    Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS Systems may be out of its manufacturing specifications. Extension springs are part of the slide alignment guide assembly. During an internal evaluation in its manufacturing facility, it was discovered that an extension spring had insufficient force. If the extension spring does not provide sufficient force, MicroSlides may not be properly positioned within the MicroSlide incubator which has the potential to cause imprecise results. Extension springs are just one component in the slide alignment assembly. OCD's evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely.

    • Terminated Z-2068-2012 FDA Class II initiated 21 May 2012 on shared 510(k) K081543

    software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment.

    • Terminated Z-1699-2012 FDA Not yet classified initiated 26 Apr 2012 on shared 510(k) K081543

    Ortho Clinical Diagnostics is recalling VITROS 5600 Integrated System Software Version 1.6 and below because of an anomaly that may inadvertently add a surfactant to a CurveTip position.

    • Terminated Z-1470-2012 FDA Not yet classified initiated 15 Mar 2012 on shared 510(k) K081543

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Systems due to possible internal hard drive failure.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JLW
Device Class
Class II
Regulation
21 CFR Part 862.1690
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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