VITROS 5600 Integrated System
Medical device recall Z-0545-2024. Published in FDA’s Enforcement Report on Dec 20, 2023.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 20, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 176 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915 Running Software Version 3.8.0
176 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,869 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide. Global Distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 10, 2023.
- FDA classified it on Dec 13, 2023.
- FDA’s Enforcement Report published it on Dec 20, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Ortho-Clinical Diagnostics, Inc., of Rochester, NY.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.