VITROS chemistry Products Cl- Slides
Medical device recall Z-0267-2020. Published in FDA’s Enforcement Report on Nov 13, 2019.
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 Nov 13, 2019. 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
- 1365545 total 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?
Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-). MicroSlides which contain reagents in a dry, multi-layered form.
1365545 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
401006613389 401006613500 401006613501 401006613608 401006613609 401006613648 401006613671 401006613712 401006613796 401006613843 401006613890 401006584017 401006614028 401006584103 401006584161 401006584214 401006584259 401006584230…
Every code shown here, 1,989 characters
401006613389 401006613500 401006613501 401006613608 401006613609 401006613648 401006613671 401006613712 401006613796 401006613843 401006613890 401006584017 401006614028 401006584103 401006584161 401006584214 401006584259 401006584230 401006644380 401006644436 401006644502 401006644529 401006644574 401006584374 401006644604 401006644649 401006644670 401006644705 401006644745 401006644800 401006644871 401006644893 401006644896 401006664973 401006665040 401006665041 401006665223 401006665225 401006665226 401006665248 401006665295 401006665227 401006665228 401006665229 401006665306 401006675376 401006675473 401006675474 401006675513 401006675514 401006675559 401006675477 401006675478 401006675501 401006675552 401006675553 401006675630 401006675631 401006675659 401006675660 401006675803 401006695852 401006695862 401006695908 401006695916 401006675801 401006675802 401006695945 401006676062 401006676063 401006696041 401006696057 401006696079 401006696093 401006767884 401006767998 401006767999 401006768049 401006767969 401006768082 401006767882 401006768133 401006767904 401006767905 401006768134 401006768149 401006768150 401006768183 401006778247 401006778277 401006778340 401006778357 401006778358 401006778470 401006798465 401006798466 401006778505 401006778559 401006778575 401006778593 401006798664 401006798665 401006798696 401006798730 401006798697 401006798835 401006798855 401006798920 401006798997 401006798998 401006799028 401006799092 401006799093 401006799138 401006799171 401006799214 401006799195 401006819270 401006819319 401006819320 401006819370 401006819538 401006819552 401006839594 401006839663 401006839699 401006839700 401006839745 401006849830 401006849832 401006849911 401006849912 401006849947 401006840040 401006840092 401006870874 401006871010 401006871011 401006871101 401006871102 401006871103 401006871164 401006871165 401006871232 401006871233 401006901842 401006901882 401006901909 401006901996 401006901997 401006913185 401006913259 401006913330…
FDA’s list runs to 2,586 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.
Domestic distribution nationwide. Foreign distribution to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, the Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, and 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?
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 Sep 10, 2019.
- FDA classified it on Nov 1, 2019.
- FDA’s Enforcement Report published it on Nov 13, 2019.
- FDA terminated it on Nov 13, 2020.
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.”
- FDA’s list of codes runs to 2,586 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
-
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.