Lower riskMedical device recall · FDA · Published March 10, 2023
Ortho-Clinical VITROS 5600 System Recall: Microtip Pack Caps May Cause Delayed Results
Ortho-Clinical recalls VITROS 5600 systems where microtip pack caps may not seal properly, causing delayed test results. Affected units have serial numbers J56000143-J56004477.
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
“Ortho-Clinical VITROS 5600 System Recall: Microtip Pack Caps May Cause Delayed Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58759-ortho-clinical-vitros-5600-system-recall-microtip-pack-caps-may. Based on FDA recall #Z-1556-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1556-2023%22&limit=1).
The FDA announced on March 10, 2023, that Ortho-Clinical Diagnostics is recalling the VITROS 5600 Integrated System due to a potentially defective MicroTip Pack Opener Assembly. This defect may cause delayed results if a pack becomes unusable.
How to tell if you have it
Brand: Ortho-Clinical
Product: VITROS 5600 Integrated System
Product Code: 6802413
UDI: 10758750002740
Serial Number Range: J56000143-J56004477
Units affected: 4895
The hazard
The MicroTip Pack Opener Assembly may fail to remove or replace MicroTip Pack Caps on VITROS 5600 and XT 7600 Integrated Systems. This malfunction can result in delayed results if a pack becomes unusable.
Context
GovInfoNow's records show Ortho-Clinical Diagnostics has issued 53 other recalls since July 10, 2017. Recent similar recalls include the Ortho-Clinical LAC Slides Recall on July 29, 2025, and the Ortho-Clinical VITROS Ca Slides Recall on July 9, 2025. Other recent recalls of similar products include the Medline Perfusion Syringe Recall (Oct. 27, 2025) and the Howmedica SCORPIO Mobile Bearing PCS Recall (July 30, 2026).
How to tell if you have this one
Check your VITROS 5600 system's serial number, which should be in the range J56000143 to J56004477. The product code is 6802413 and UDI is 10758750002740.
Brand
Ortho-Clinical
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
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
Recall number
Product, codes & lots
Quantity
Z-1555-2023
VITROS XT 7600 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: 6844461; UDI: 10758750031610 Serial Number Range: J76000109- J76001492
2001 units
Z-1556-2023
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; UDI: 10758750002740 Serial Number Range: J56000143- J56004477
4895 units
Z-1557-2023
VITROS 5600 Integrated System - Refurbished . 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: 6802915; UDI: 10758750007110 Serial Number Range: J56000147- J56003653
1148 units
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Verify your VITROS 5600 system's serial number falls within the range J56000143 to J56004477.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1556-2023 (March 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1556-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.