CLASS II ONGOING Device recall · Reported 13 Mar 2024 · FDA Enforcement Report

Vitros 5600 Integrated System recalled by Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics is recalling Vitros 5600 Integrated System, distributed nationwide in the US. The recall was initiated on 26 Jan 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVITROS System Software Versions 3.8.0 or 3.8.1 Regular UDI-DI 10758750002740 Refurbished UD-DI 10758750007110 Serial Numbers: US: J56000116 J56003369 J56000317 J56003373 J56001292 J56003377 J56001523 J56003433 J56001629 J56003477 J56001885 J56003478 J56001886 J56003484 J56001910 J56003496 J56002041 J56003541 J56002159 J56003570 J56002198 J56003578 J56002199 J56003581 J56002201 J56003583 J56002249 J56003632 J56002301 J56003646 J56002308 J56003655 J56002461 J56003668 J56002463 J56003669 J56002466 J56003670 J56002474 J56003672 J56002477 J56003725 J56002500 J56003730 J56002591 J56003752 J56002603 J56003759 J56002607 J56003774 J56002608 J56003911 J56002615 J56004068 J56002698 J56004137 J56002703 J56004174 J56002704 J56004240 J56002722 J56004325 J56002769 J56004326 J56002895 J56004485 J56003035 J56004491 J56003045 J56004498 J56003076 J56004506 J56003113 J56004512 J56003199 J56004549 J56003220 J56004551 J56003287 J56004571 J56003299 J56004577 J56003317 J56004587 J56003330 J56004589 J56003334 J56004604 J56003342 J56004606 J56003356 OUS: J56000190 J56001929 J56000246 J56001944 J56000418 J56001979 J56000425 J56002028 J56000468 J56002064 J56000512 J56002085 J56000533 J56002099 J56000665 J56002116 J56000671 J56002218 J56000674 J56002258 J56000680 J56002300 J56000719 J56002410 J56000809 J56002460 J56000831 J56002518 J56000836 J56002615 J56000910 J56002625 J56000929 J56002637 J56000993 J56002784 J56000994 J56002821 J56001015 J56002862 J56001051 J56002913 J56001097 J56002926 J56001111 J56002929 J56001114 J56002966 J56001140 J56003061 J56001208 J56003162 J56001210 J56003179 J56001237 J56003260 J56001260 J56003285 J56001320 J56003401 J56001355 J56003451 J56001378 J56003464 J56001389 J56003508 J56001469 J56003523 J56001509 J56003538 J56001591 J56003919 J56001631 J56003951 J56001689 J56004078 J56001731 J56004082 J56001733 J56004308 J56001765 J56004309 J56001780 J56004346 J56001793 J56004355 J56001826 J56004414 J56001844 J56004415 J56001853 J56004531 J56001925 J56004695

Quantity recalled91 US; 94 OUS

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-1231-2024
FDA event ID: 93927
Recalling firm: Ortho-Clinical Diagnostics, Rochester, NY
Classification: Class II
Status: Ongoing
Recall initiated: 26 Jan 2024
FDA classified: 1 Mar 2024
Reported: 13 Mar 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

26 Jan 2024	Recall initiated by company
1 Mar 2024	Classified by FDA	+35 days
13 Mar 2024	Published in enforcement report	+12 days

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

Reason for recall

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)

Where it was distributed

Worldwide distribution - US Nationwide and the countries of 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

Questions about this recall

Is Vitros 5600 Integrated System recalled?

Yes. Ortho-Clinical Diagnostics recalled Vitros 5600 Integrated System on 26 Jan 2024. The recall is Class II and its status is Ongoing. Recall number Z-1231-2024.

Why was it recalled?

Which lots are affected?

VITROS System Software Versions 3.8.0 or 3.8.1 Regular UDI-DI 10758750002740 Refurbished UD-DI 10758750007110 Serial Numbers: US: J56000116 J56003369 J56000317 J56003373 J56001292 J56003377 J56001523 J56003433 J56001629 J56003477 J56001885 J56003478 J56001886 J56003484 J56001910 J56003496 J56002041 J56003541 J56002159 J56003570 J56002198 J56003578 J56002199 J56003581 J56002201 J56003583 J56002249 J56003632 J56002301 J56003646 J56002308 J56003655 J56002461 J56003668 J56002463 J56003669 J56002466 J56003670 J56002474 J56003672 J56002477 J56003725 J56002500 J56003730 J56002591 J56003752 J56002603 J56003759 J56002607 J56003774 J56002608 J56003911 J56002615 J56004068 J56002698 J56004137 J56002703 J56004174 J56002704 J56004240 J56002722 J56004325 J56002769 J56004326 J56002895 J56004485 J56003035 J56004491 J56003045 J56004498 J56003076 J56004506 J56003113 J56004512 J56003199 J56004549 J56003220 J56004551 J56003287 J56004571 J56003299 J56004577 J56003317 J56004587 J56003330 J56004589 J56003334 J56004604 J56003342 J56004606 J56003356 OUS: J56000190 J56001929 J56000246 J56001944 J56000418 J56001979 J56000425 J56002028 J56000468 J56002064 J56000512 J56002085 J56000533 J56002099 J56000665 J56002116 J56000671 J56002218 J56000674 J56002258 J56000680 J56002300 J56000719 J56002410 J56000809 J56002460 J56000831 J56002518 J56000836 J56002615 J56000910 J56002625 J56000929 J56002637 J56000993 J56002784 J56000994 J56002821 J56001015 J56002862 J56001051 J56002913 J56001097 J56002926 J56001111 J56002929 J56001114 J56002966 J56001140 J56003061 J56001208 J56003162 J56001210 J56003179 J56001237 J56003260 J56001260 J56003285 J56001320 J56003401 J56001355 J56003451 J56001378 J56003464 J56001389 J56003508 J56001469 J56003523 J56001509 J56003538 J56001591 J56003919 J56001631 J56003951 J56001689 J56004078 J56001731 J56004082 J56001733 J56004308 J56001765 J56004309 J56001780 J56004346 J56001793 J56004355 J56001826 J56004414 J56001844 J56004415 J56001853 J56004531 J56001925 J56004695

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.

More recalls from Ortho-Clinical Diagnostics

All 311

Reported	Class	Recall	Company	Reason	Where
24 Sep 2025Device	CLASS II	Chemistry Products LAC Slides recalled by Ortho-Clinical Diagnostics	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
24 Sep 2025Device	CLASS II	Vitros Chemistry Products LAC Slides recalled	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
27 Aug 2025Device	CLASS II	Vitros Chemistry Products Ca Slides recalled	Ortho-Clinical Diagnostics	Device Malfunction	Nationwide
23 Jul 2025Device	CLASS II	Vitros Chemistry Products CHE Slides (Japan) recalled	Ortho-Clinical Diagnostics	Labeling Errors	Nationwide
23 Jul 2025Device	CLASS II	Vitros Chemistry Products CHE Slides recalled	Ortho-Clinical Diagnostics	Labeling Errors	Nationwide

Other Other Medical Devices recalls

All 13,771

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ortho Aspiration Kit recalled	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Arterial Line Insertion Kit recalled	Medline Industries	Sterility	Nationwide