Ortho Clinical Diagnostics VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
Brand
Ortho Clinical Diagnostics
Lot Codes / Batch Numbers
Affected Serial Number Range: J76000111-J76000525
Products Sold
Affected Serial Number Range: J76000111-J76000525
Ortho Clinical Diagnostics is recalling VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique due to Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
Recommended Action
Per FDA guidance
Ortho Clinical Diagnostics issued on 20 May 2020, Customer letter (Ref. CL2020-126) sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all VITROS 3600, 5600 and XT7600 . Letter states reason for recall, health risk, and action to take: In the meantime, manually adding the values in both the serum screen AND the plasma screen (even though the plasma screen appears to be updated already) will prevent the issue by correctly marking the edits to both body fluids with M1. To manually enter these values for Plasma in Options & Configurations: navigate to Plasma, select the assay, select Review/Edit Configuration, edit Qualitative fields to match Serum. If it appears they currently match, retype at least one of the changes, then touch Save. Once the Qualitative Range values have been updated, load an ADD using Retain Configuration. Verify that both Serum and Plasma values match the intended modifications. This indicates that the modifications were marked with a M1 code and will continue to be retained when that option is used during future ADD loads. " A review of previously reported patient results is recommended if you identify an assay modification in which Serum and Plasma do not match. Review Plasma sample results for these assays versus your intended thresholds. Note: if your VITROS System is connected via e-connectivity, the Ortho Care Technical Solutions Center can assist you with obtaining your patient results from the past 90 days. " If you believe this software anomaly has affected sample results in your laboratory, please contact Ortho Care Technical Solutions Center. " Complete the Confirmation of Receipt form Foreign affiliates were informed by email approximately on 20 May 2020 of the issue and instructed to notify their consignees of the issue and required actions until the software mitigation is available. The anomaly will be resolved with software version
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026