FDA Medical Device Recalls (openFDA)
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 number
- Z-1556-2023
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2023-03-10
- Posted
- 2023-05-04
- Terminated
- not on file
- Reason
- 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
- Root cause
- Under Investigation by firm
- Action
- 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
- Quantity
- 4895 units
- Distribution
- Nationwide including Puerto Rico and Bermuda Foreign: Australia Belgium Brazil Canada Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Portugal Russia Singapore Spain Sweden The Netherlands United Kingdom
- Lot, serial or model codes
- UDI: 10758750002740 Serial Number Range: J56000143- J56004477
- 510(k) numbers
- ["K081543"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 2250051
- Firm city
- Raritan
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28