Use caution Medical device recall · FDA · Published October 10, 2023

Ortho-Clinical VITROS XT 3400 Software Version 3.8.0 May Cause Delayed Test Results

Ortho-Clinical recalls VITROS XT 3400 Chemistry System with software version 3.8.0 due to potential delays in critical test results. Affected units may experience screen freezes or printer disconnections, risking treatment delays for patients needing urgent care.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0546-2024Medical device Ortho-Clinical ›

Use caution until it’s fixed

During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.

Take action

Contact the company

Recalling firmOrtho-Clinical Diagnostics, Inc.100 Indigo Creek Dr · Rochester, NY 14626-5101

✎ GovInfoNow plain-language explainer

Ortho-Clinical is recalling VITROS XT 3400 Chemistry Systems with software version 3.8.0 because this version can cause screen freezes or printer disconnections. These issues might delay critical test results, potentially affecting urgent patient treatment. Read more at govinfonow.com/recall/57104-ortho-clinical-vitros-xt-3400-software-version-3-8-0.

Source Summary by GovInfoNow · govinfonow.com/recall/57104-ortho-clinical-vitros-xt-3400-software-version-3-8-0 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0546-2024

Cite this page

“Ortho-Clinical VITROS XT 3400 Software Version 3.8.0 May Cause Delayed Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57104-ortho-clinical-vitros-xt-3400-software-version-3-8-0. Based on FDA recall #Z-0546-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0546-2024%22&limit=1).

Ortho-Clinical Diagnostics, Inc. voluntarily recalled 51 VITROS XT 3400 Chemistry Systems with software version 3.8.0 due to potential system freezes and printer disconnections that could delay critical test results, the FDA said on Oct. 10, 2023.

How to tell if you have it

Brand: Ortho-Clinical
Product: VITROS XT 3400 Chemistry System
Product Code: 6844458
Software Version: 3.8.0
Serial Numbers: J34500140, J34500113, J34500180, J34500114, J34500257, J34500116, J34500289, J34500117, J34500319, J34500123, J34500386, J34500128, J34500422, J34500129, J34500447, J34500130, J34500473, J34500139, J34500474, J34500190, J34500510, J34500261, J34500539, J34500269, J34500547, J34500271, J34500579, J34500292, J34500588, J34500301, J34500622, J34500337, J34500656, J34500356, J34500777, J34500363, J34500818, J34500515, J34500887, J34500520, J34500893, J34500536, J34500896, J34500582, J34500911, J34500609, J34500931, J34500628, J34500658, J34500711, J34500793

The hazard

The recall addresses software issues including unresponsive subsystems, screen freezes, and printer disconnections identified after the release of Software Version 3.8.0. These failures require system shutdowns to recover, which delays reporting results during any assay, including STAT tests that determine critical patient treatment speed.

Context

GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since July 10, 2017. Other recent recalls of similar products include Ortho-Clinical LAC Slides Recall (July 29, 2025), Ortho-Clinical VITROS Ca Slides Recall (July 9, 2025), and Ortho-Clinical VITROS OP Reagent Gen 15 May Cause Inaccurate Test Results (June 12, 2025). Beckman Coulter UniCel Dxl 600 recalls issued Nov. 26, 2025, and Beckman Coulter DxC 700 AU Recall issued Jan. 30, 2026, also involve delayed test results.

How to tell if you have this one

Check if your VITROS XT 3400 Chemistry System has software version 3.8.0. Affected units have specific serial numbers listed in the recall notice.

Brand
Ortho-Clinical
Category
Medical device

FDA recall event · 5 products

All 5 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
US Nationwide. Global Distribution.

Recall number	Product, codes & lots	Quantity
Z-0543-2024	VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0; Product Code: 6802783, UDI-DI: 10758750002979; Product Code: 6802914, UDI-DI: 10758750007103; Serial Numbers: J36000109 J36000294 J36001012 J36001489 J36000292 J36000340 J36001024 J36001495 J36000484 J36000348 J36001027 J36001513 J36000489 J36000446 J36001051 J36001515 J36000955 J36000511 J36001088 J36001519 J36001151 J36000517 J36001108 J36001528 J36001167 J36000580 J36001111 J36001535 J36001222 J36000688 J36001112 J36001570 J36001283 J36000753 J36001117 J36001573 J36001330 J36000861 J36001237 J36001575 J36001348 J36000877 J36001245 J36001579 J36000920 J36001246 J36001581 J36000923 J36001401 J36001582 J36000929 J36001403 J36001583 J36000933 J36001427 J36001600 J36000941 J36001451 J36001602 J36000942 J36001488 J36001618 J36001000	63 units
Z-0544-2024	VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0; Product Code: 6802445, UDI-DI: 10758750012343; Product Code: 6900440, UDI-DI: 10758750033201; Serial Numbers: J46000208 J46000019 J46000861 J46000209 J46000020 J46000910 J46000240 J46000150 J46000983 J46000497 J46000162 J46001029 J46000864 J46000247 J46001041 J46000865 J46000296 J46001042 J46000898 J46000393 J46001119 J46001030 J46000410 J46001210 J46001064 J46000478 J46001217 J46001125 J46000499 J46001289 J46001132 J46000531 J46001541 J46001252 J46000564 J46001565 J46001293 J46000617 J46001609 J46001462 J46000772 J46001629 J46001703 J46000788 J46001639 J46001704 J46000800 J46001645 J46000820 J46001680 J46000859	51 units
Z-0545-2024	VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0; Product Code: 6802413, UDI-DI: 10758750002740; Product Code: 6802915, UDI-DI: 10758750007110; Serial Numbers: J56000116 J56003330 J56000102 J56001793 J56000317 J56003334 J56000161 J56001826 J56001292 J56003342 J56000246 J56001844 J56001523 J56003356 J56000252 J56001925 J56001629 J56003369 J56000418 J56001929 J56001885 J56003373 J56000425 J56001944 J56001886 J56003377 J56000468 J56001979 J56001910 J56003416 J56000512 J56002028 J56002041 J56003433 J56000533 J56002099 J56002064 J56003477 J56000665 J56002116 J56002159 J56003478 J56000671 J56002218 J56002196 J56003484 J56000680 J56002258 J56002198 J56003496 J56000719 J56002300 J56002199 J56003541 J56000831 J56002410 J56002201 J56003570 J56000836 J56002410 J56002249 J56003578 J56000910 J56002460 J56002301 J56003581 J56000929 j56002615 J56002308 J56003583 J56000972 J56002625 J56002358 J56003632 J56000980 J56002625 J56002461 J56003646 J56000993 J56002637 J56002463 J56003655 J56000994 J56002821 J56002466 J56003668 J56001015 J56002862 J56002474 J56003669 J56001097 J56002913 J56002477 J56003670 J56001111 J56002913 J56002500 J56003672 J56001140 J56002966 J56002591 J56003725 J56001208 J56003162 J56002603 J56003730 J56001260 J56003179 J56002607 J56003752 J56001320 J56003260 J56002608 J56003759 J56001355 J56003401 J56002698 J56003774 J56001378 J56003451 J56002703 J56003911 J56001389 J56003508 J56002704 J56003919 J56001469 J56004078 J56002719 J56004068 J56001509 J56004082 J56002722 J56004137 J56001631 J56004308 J56002769 J56004174 J56001689 J56004309 J56002874 J56004240 J56001731 J56004355 J56002895 J56004325 J56001765 J56004414 J56002935 J56004326 J56001780 J56004531 J56002955 J56004485 J56003035 J56004498 J56003037 J56004506 J56003045 J56004512 J56003076 J56004549 J56003113 J56004551 J56003190 J56004571 J56003199 J56004577 J56003220 J56004587 J56003287 J56004589 J56003299 J56004604 J56003317 J56004606	176 units
Z-0546-2024	VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0; Product Code: 6844458, UDI-DI: 10758750031986; Serial Numbers: J34500140 J34500113 J34500180 J34500114 J34500257 J34500116 J34500289 J34500117 J34500319 J34500123 J34500386 J34500128 J34500422 J34500129 J34500447 J34500130 J34500473 J34500139 J34500474 J34500190 J34500510 J34500261 J34500539 J34500269 J34500547 J34500271 J34500579 J34500292 J34500588 J34500301 J34500622 J34500337 J34500656 J34500356 J34500777 J34500363 J34500818 J34500515 J34500887 J34500520 J34500893 J34500536 J34500896 J34500582 J34500911 J34500609 J34500931 J34500628 J34500658 J34500711 J34500793	51 units
Z-0547-2024	VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0; Product Code: 6844461, UDI-DI: 10758750031610; Serial Numbers: J76000050 J76000878 J76001555 J76000033 J76000976 J76000108 J76000905 J76001558 J76000036 J76000983 J76000144 J76000909 J76001559 J76000043 J76001001 J76000148 J76000922 J76001565 J76000045 J76001027 J76000192 J76000930 J76001570 J76000106 J76001035 J76000195 J76000968 J76001577 J76000118 J76001070 J76000199 J76001106 J76001581 J76000211 J76001074 J76000200 J76001171 J76001583 J76000253 J76001095 J76000206 J76001172 J76001589 J76000257 J76001111 J76000207 J76001206 J76001592 J76000265 J76001121 J76000208 J76001207 J76001595 J76000274 J76001130 J76000241 J76001218 J76001596 J76000276 J76001141 J76000298 J76001230 J76001597 J76000278 J76001142 J76000313 J76001231 J76001599 J76000280 J76001144 J76000317 J76001232 J76001600 J76000281 J76001152 J76000324 J76001235 J76001611 J76000284 J76001155 J76000333 J76001239 J76001616 J76000288 J76001159 J76000342 J76001260 J76001617 J76000289 J76001174 J76000352 J76001263 J76001620 J76000290 J76001183 J76000353 J76001274 J76001638 J76000292 J76001189 J76000420 J76001292 J76001639 J76000293 J76001272 J76000422 J76001293 J76001643 J76000318 J76001273 J76000456 J76001294 J76001644 J76000370 J76001285 J76000459 J76001331 J76001647 J76000436 J76001309 J76000460 J76001340 J76001648 J76000446 J76001314 J76000468 J76001351 J76001650 J76000447 J76001328 J76000495 J76001357 J76001652 J76000618 J76001368 J76000502 J76001370 J76001659 J76000620 J76001377 J76000524 J76001376 J76001660 J76000628 J76001378 J76000525 J76001383 J76001666 J76000760 J76001379 J76000561 J76001384 J76001667 J76000782 j76001396 J76000609 J76001385 J76001668 J76000807 J76001399 J76000709 J76001392 J76001669 J76000838 J76001407 J76000743 J76001404 J76001671 J76000845 J76001408 J76000747 J76001406 J76001674 J76000855 J76001452 J76000783 J76001516 J76001675 J76000856 J76001457 J76000790 J76001517 J76001678 J76000888 J76001484 J76000803 J76001518 J76001679 J76000898 J76001547 J76000805 J76001519 J76001687 J76000901 J76001562 J76000806 J76001520 J76001692 J76000973 J76001563 J76000817 J76001535 J76001700 J76000862 J76001540 J76001703 J76000866 J76001549 J76001705 J76000868 J76001552 J76001711 J76000871 J76001553 J76001714 J76000873	216 units

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your system's software version by checking the device settings or documentation.
Contact Manufacturer
Reach out to Ortho-Clinical Diagnostics for guidance on resolving the issue or updating the software.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide. Global Distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

Oct 10, 2023Firm started the recall
Dec 13, 2023FDA classified it Class II
Dec 20, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/57104-ortho-clinical-vitros-xt-3400-software-version-3-8-0">Ortho-Clinical VITROS XT 3400 Software Version 3.8.0 May Cause Delayed Test Results (GovInfoNow)</a>

Where this comes from

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-0546-2024 (October 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0546-2024 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.