Ortho-Clinical Diagnostics, Inc. VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents Product Code: 6802413 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 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents Product Code: 6802413
Brand
Ortho-Clinical Diagnostics, Inc.
Lot Codes / Batch Numbers
UDI: 10758750002740 Serial Number Range: J56000143- J56004477
Products Sold
UDI: 10758750002740 Serial Number Range: J56000143- J56004477
Ortho-Clinical Diagnostics, Inc. is recalling VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitat due to MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS 5600 and XT 7600 Integrated Systems, results may be d. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Ortho Clinical issued Important Product Correction letter on 3/10/23 to customers with VITROS XT7600 & 5600 Integrated Systems (CL2023-061) and instructed: Until further notice, Ortho recommends loosening and then retightening all caps for MicroTip reagents or diluents immediately prior to loading them onto the system. Per the V-Docs/Maintenance Troubleshooting Guide instructions, Manual MicroTip Reagent Pack Cap Removal, Chapter 6 Troubleshooting, Remove reagent pack caps manually if they become too tight for the MICROTIP PACK OPENER to uncap. The purpose of executing this procedure is to loosen the caps without removing them, and then manually tighten the caps. For VITROS 5600: J33044 Chapter 6 Troubleshooting: Manual MicroTip Reagent Pack Cap Removal. For VITROS XT7600 Chapter 6 Troubleshooting: Manual MicroTip Reagent Pack Cap Removal " Complete the enclosed Confirmation of Receipt form no later than March 24, 2023. " Please forward this notification if the affected product was distributed outside of your facility. " Save this notification with your user documentation or post this notification by each VITROS 5600 or XT 7600 System until root cause investigation is completed. " If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Ortho Care" Technical Solutions Center. Contact Information 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