CytoVision Image Analysis and Capture System, an automated cell-locating device
Medical device recall Z-2039-2016. Published in FDA’s Enforcement Report on Jun 29, 2016.
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 Jun 29, 2016. Copied from openFDA on Oct 20, 2026.
- Class III FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 283 systems 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 III, the least serious of FDA’s three classes.
“Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”
openFDA, in plain words, its enforcement report fields.
“Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
FDA’s rule, 21 CFR 7.3(m)(3), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. The system appears to be unlicensed. These systems cannot be re-activated using standard Windows licensing procedures and are requiring checks of each potentially affected system to confirm Windows 7 OS is properly activated.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
283 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
System 23CAP001KXX001 with Serial Number 201021, System 23CAP001KXX001 with Serial Number 201020, System 23CAP001KXX001 with Serial Number 200994, System 23CAP001KFX001 with Serial Number 200752, System 23GSLXXXKFXUPG with Serial Number…
Every code shown here, 1,996 characters
System 23CAP001KXX001 with Serial Number 201021, System 23CAP001KXX001 with Serial Number 201020, System 23CAP001KXX001 with Serial Number 200994, System 23CAP001KFX001 with Serial Number 200752, System 23GSLXXXKFXUPG with Serial Number 201013, System 23GSLXXXKFXUPG with Serial Number 201050, System 23CAP007FXX001 with Serial Number 200930, System 23CAP002KFX001 with Serial Number 201000, System 23CAP001KXX001 with Serial Number 200969, System 23CAP001KFX001 with Serial Number 200942, System 23GSL120KFX001 with Serial Number 200910, System 23CAP001FXX001 with Serial Number 200710, System 23GSLXXXKFXUPG with Serial Number 200890, System 23GSL120KFX001 with Serial Number 201001System 23CAP002FXX001 with Serial Number 200889, System 23GSLXXXKFXUPG with Serial Number 201087, System 23CUP003CVX720 with Serial Number 201086, System 23GSL10XKXX001 with Serial Number 201085, System 23REV001XXX001 with Serial Number 201084, System 23REV001XXX001 with Serial Number 201083, System 23REV001XXX001 with Serial Number 201082, System 23REV001XXX001 with Serial Number 201081, System 23REV001XXX001 with Serial Number 201080, System 23REV001XXX001 with Serial Number 201079, System 23REV001XXX001 with Serial Number 201078, System 23REV001XXX001 with Serial Number 201077, System 23REV001XXX001 with Serial Number 201076, System 23CUP001CVX720 with Serial Number 201056 System 23CUP001CVMV4 with Serial Number 200921, System 23CUP001CVX720 with Serial Number 200920, System 23CAP001FXX001 with Serial Number 201004, System 23CUP001CVX720 with Serial Number 200922, System 23CUP003CVX720 with Serial Number 200749, System 23CUP001CVX720 with Serial Number 200748, System 23CUP001CVX720 with Serial Number 200747, System 23CUP001CVX720 with Serial Number 200996, System 23CUP003CVX720 with Serial Number 200980, System 23REV000KXX001 with Serial Number 200973, System 23REV000KXX001 with Serial Number 200972, System 23REV000KXX001 with Serial Number 200971, System 23CW4000UP002 with Serial Number…
FDA’s list runs to 13,886 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; Portugal, Spain, Thailand, Italy, China, Romania, Egypt, India, France, Hungary, Mexico, Germany, Norway, Turkey, Pakistan, Malaysia, UK, Luxembourg, Israel, Canada, Switzerland, Taiwan, South Africa, Saudi Arabia, Korea, Singapore and Japan.
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 May 2, 2016.
- FDA classified it on Jun 20, 2016.
- FDA’s Enforcement Report published it on Jun 29, 2016.
- FDA terminated it on Dec 13, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Leica Biosystems Richmond Inc., of Richmond, IL.
- 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 13,886 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.