VITROS XT 7600 Integrated System
Medical device recall Z-1233-2024. Published in FDA’s Enforcement Report on Mar 13, 2024.
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 Mar 13, 2024. 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
- 142 US; 78 OUS 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?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
VITROS XT 7600 Integrated System, Catalog No. 6844461
142 US; 78 OUS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
VITROS System Software Versions 3.8.0 or 3.8.1 UDI-DI 10758750031610 Serial Numbers: US: J76000050 J76000878 J76001555 J76000108 J76000905 J76001558 J76000144 J76000909 J76001559 J76000148 J76000922 J76001565 J76000179 J76000930 J76001570…
Every code shown here, 1,994 characters
VITROS System Software Versions 3.8.0 or 3.8.1 UDI-DI 10758750031610 Serial Numbers: US: J76000050 J76000878 J76001555 J76000108 J76000905 J76001558 J76000144 J76000909 J76001559 J76000148 J76000922 J76001565 J76000179 J76000930 J76001570 J76000192 J76000968 J76001577 J76000195 J76001106 J76001581 J76000199 J76001171 J76001583 J76000200 J76001172 J76001589 J76000206 J76001206 J76001592 J76000207 J76001207 J76001595 J76000208 J76001218 J76001596 J76000241 J76001230 J76001597 J76000298 J76001231 J76001599 J76000313 J76001232 J76001600 J76000317 J76001234 J76001611 J76000324 J76001235 J76001616 J76000333 J76001239 J76001617 J76000342 J76001260 J76001620 J76000352 J76001263 J76001638 J76000353 J76001270 J76001639 J76000420 J76001274 J76001643 J76000422 J76001292 J76001644 J76000456 J76001293 J76001647 J76000459 J76001294 J76001648 J76000460 J76001331 J76001650 J76000468 J76001340 J76001652 J76000495 J76001351 J76001659 J76000502 J76001357 J76001660 J76000524 J76001370 J76001666 J76000525 J76001376 J76001667 J76000537 J76001383 J76001668 J76000561 J76001384 J76001669 J76000609 J76001385 J76001671 J76000709 J76001392 J76001674 J76000743 J76001404 J76001675 J76000747 J76001406 J76001678 J76000783 J76001516 J76001679 J76000790 J76001517 J76001687 J76000803 J76001518 J76001692 J76000805 J76001519 J76001700 J76000806 J76001520 J76001703 J76000817 J76001535 J76001705 J76000862 J76001540 J76001711 J76000866 J76001549 J76001714 J76000868 J76001552 J76001748 J76000871 J76001553 J76001879 J76000873 OUS: J76000106 J76000976 J76000118 J76000983 J76000211 J76001001 J76000253 J76001027 J76000257 J76001035 J76000265 J76001070 J76000274 J76001074 J76000276 J76001095 J76000278 J76001111 J76000280 J76001121 J76000281 J76001130 J76000284 J76001141 J76000288 J76001142 J76000289 J76001144 J76000290 J76001152 J76000292 J76001155 J76000293 J76001159 J76000370 J76001174 J76000436 J76001183 J76000446 J76001189 J76000447 J76001272 J76000475 J76001273 J76000620 J76001285 J76000628 J76001309…
FDA’s list runs to 2,293 characters. The first part is shown; the rest is on FDA’s record.
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.
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.
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.
The words say it went outside the United States too.
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 Jan 26, 2024.
- FDA classified it on Mar 1, 2024.
- FDA’s Enforcement Report published it on Mar 13, 2024.
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.”
- FDA’s list of codes runs to 2,293 characters; the first part is shown here, and the rest is on FDA’s record.
- 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
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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.