Ortho-Clinical Diagnostics, Inc. VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
Brand
Ortho-Clinical Diagnostics, Inc.
Lot Codes / Batch Numbers
UDI-DI: 10758750031986 Systems start with 3400XXXX where XXXX is unique for each analyzer
Products Sold
UDI-DI: 10758750031986 Systems start with 3400XXXX where XXXX is unique for each analyzer
Ortho-Clinical Diagnostics, Inc. is recalling VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458 due to Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
Recommended Action
Per FDA guidance
Ortho CLinical issued Urgent Medical Device Correction letter on 19 July 2022 to consignees who received a VITROS XT3400 or a VITROS XT7600 System notified via (CL2020-176) of the issue and instructed to: " If your VITROS XT 3400 and/or VITROS XT 7600 Systems require a system shutdown, routine Quality Control processing for MicroSlide assays must be performed per your laboratory procedure, prior to processing patient samples, to determine if the anomaly has occurred. " If QC results are outside your established ranges, Ortho recommends performing a second system shutdown and re-processing QC fluids for those assays that were outside your established ranges. If QC results are still outside established ranges following a second system shutdown, contact Ortho Care" Technical Solutions Center for guidance. " Ortho recommends using the same vial of QC fluids (where possible) throughout these steps to determine if the anomaly has occurred. Refer to the control storage and stability documentation for fluid stability guidelines once opened or reconstituted. " Post this notification by each VITROS XT 3400 and/or XT 7600 System until this issue is resolved. Ortho is currently investigating this issue; a follow-up communication will be released once our investigation is complete. " Complete the enclosed Confirmation of Receipt no later than July 26, 2022. If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
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