VITROS 5600 Integrated System- (Refurbished)
Medical device recall Z-0080-2019. Published in FDA’s Enforcement Report on Oct 17, 2018.
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 Oct 17, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- U.S.= 66 ex-U.S.= 76 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?
Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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, Catalog Number: 6802915
U.S.= 66 ex-U.S.= 76, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: US: 56000718 56001062 56000458 56000824 56000315 56001235 56000786 56000747 56000339 56000559 56000308 56000727 56000741 56000792 56000750 56000825 56001012 56001641 56001131 56000818 56000327 56000661 56000255 56001021…
Every code shown here, 1,312 characters
Serial Numbers: US: 56000718 56001062 56000458 56000824 56000315 56001235 56000786 56000747 56000339 56000559 56000308 56000727 56000741 56000792 56000750 56000825 56001012 56001641 56001131 56000818 56000327 56000661 56000255 56001021 56000533 56001111 56001689 56001152 56001141 56000756 56000585 56000427 56000261 56001570 56001535 56001139 56000317 56001184 56001530 56001558 56001334 56001437 56000883 56001445 56000186 56000308 56000315 56000327 56000339 56000458 56000559 56000718 56000727 56000741 56000747 56000750 56000786 56000792 56000824 56000825 56001062 56001235 56001635 56001641 56000568 56001153 OUS: Serial No 56000362 56000528 56000245 56000283 56000330 56000377 56000399 56000413 56000437 56000464 56000634 56000740 56000740 56000749 56000758 56000758 56000759 56000759 56000826 56001246 56001461 56001461 56000438 56000414 56000416 56000528 56000555 56000642 56000560 56000537 56000867 56000515 56001487 56000200 56000331 56000428 56000463 56000466 56000632 56000923 56000416 56000567 56001487 56000539 56000459 56000642 56000669 56001482 56000439 56000555 56000147 56000179 56000214 56000260 56000277 56000415 56000426 56000535 56000582 56000680 56000820 56000827 56000994 56001133 56001135 56001451 56001859 56000393 56001027 56000646 56001128 56000655 56000796 56001359 56001851 56000928
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.
Nationwide Foreign: France, Brazil, Chile, Great Britain, Phillippines, Spain
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?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Aug 15, 2018.
- FDA classified it on Oct 5, 2018.
- FDA’s Enforcement Report published it on Oct 17, 2018.
- FDA terminated it on Jan 10, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Ortho-Clinical Diagnostics, 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
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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.