CLASS II ONGOING Device recall · Reported 10 May 2023 · FDA Enforcement Report

Vitros 5600 Integrated System - Refurbished . For use recalled

Ortho-Clinical Diagnostics is recalling Vitros 5600 Integrated System - Refurbished . For use in the in vitro quantitative, distributed nationwide in the US. The recall was initiated on 10 Mar 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 10758750007110 Serial Number Range: J56000147- J56003653

Quantity recalled1148 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1557-2023
FDA event ID: 92055
Recalling firm: Ortho-Clinical Diagnostics, Raritan, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 10 Mar 2023
FDA classified: 4 May 2023
Reported: 10 May 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

10 Mar 2023	Recall initiated by company
4 May 2023	Classified by FDA	+55 days
10 May 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Puerto Rico

Questions about this recall

Is Vitros 5600 Integrated System - Refurbished . For use in the in vitro quantitative recalled?

Yes. Ortho-Clinical Diagnostics recalled Vitros 5600 Integrated System - Refurbished . For use in the in vitro quantitative on 10 Mar 2023. The recall is Class II and its status is Ongoing. Recall number Z-1557-2023.

Why was it recalled?

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

Which lots are affected?

UDI: 10758750007110 Serial Number Range: J56000147- J56003653

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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