The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line
Medical device recall Z-1077-2019. Published in FDA’s Enforcement Report on Apr 10, 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 Apr 10, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 26 states named in where it went
- 2842 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?
When racks are front-loaded onto the sample presentation unit while samples from the automation line are being processed, a scheduling error within the software can cause mishandling of samples during the creation of an aliquot and lead to incorrect results being generated. Affected samples typically yield non-reproducible falsely decreased results by up to 100%, however the potential for falsely elevated results cannot be ruled out.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
2842, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Systems running software versions: 5.2, 5.3.0, 5.3.1. Serial #: 605042 605047 605048 605050 606363 606439 901612 901626 605300 605301 605516 900777 605636 606566 606567 606383 606744 606745 605996 606161 606169 606231 606500 606565 606155…
Every code shown here, 1,996 characters
Systems running software versions: 5.2, 5.3.0, 5.3.1. Serial #: 605042 605047 605048 605050 606363 606439 901612 901626 605300 605301 605516 900777 605636 606566 606567 606383 606744 606745 605996 606161 606169 606231 606500 606565 606155 606156 606302 606740 606743 604566 604622 604624 604627 604713 606646 606746 604912 604951 606128 606386 606324 605932 606755 603377 604309 605909 604410 605372 604178 604426 604796 604744 602700 603298 603660 603797 603897 605762 604608 606411 604345 602472 603059 603513 603837 601829 602930 603217 604703 605201 605216 606557 604207 604929 605768 605769 605978 602139 606572 602417 601931 606104 602469 604115 604947 604682 604733 601919 602088 606201 601852 604699 605302 603647 606090 602077 602601 605449 603250 605199 605736 604827 603609 605492 604628 602084 602310 605211 605633 606763 606770 602074 604307 606257 604046 602063 603338 603481 604940 605179 602091 604080 606467 604698 602422 605812 604150 603255 605653 605923 603268 605894 601988 605172 602487 605212 605735 603231 603531 604457 602259 606089 602772 606455 604602 604730 604743 605133 603953 602489 605346 605076 604927 605712 604741 604739 605683 604767 604130 602618 602657 606210 604471 606353 603358 603368 604482 603811 603603 603226 602866 603390 602878 602833 605931 601881 606592 603955 602462 602522 606237 600742 602147 602058 603991 604768 605141 605893 605454 603893 603253 603346 603996 602359 602671 602856 603382 603427 603442 604653 602435 604725 604141 604842 601697 602915 603375 604953 605376 603239 603980 605504 605569 606129 602810 602477 605389 603022 604580 604025 601707 601926 602357 602389 602400 603139 603288 603533 602863 605355 605359 605539 602433 606018 606177 606238 606402 606585 606589 606602 606651 606712 606714 606715 606716 606717 606718 606725 606898 606903 605597 604934 604065 603964 603223 603233 605376 603199 604220 606704 603121 603661 604000 603780 603783 601096 604311 606190 603784 604604 606463 606722 604829 605037 605688 602140…
FDA’s list runs to 19,957 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.
US: NJ, OH, NY, GA, FL, TN, WI, MI, MS, CA, NC, TX, PA, DC, IN, KY, IL, WA, MN, LA, ND, ID, WV, AK, AL, MA. OUS: Argentina, Australia, Bahrain, Canada, China, Croatia, Czech Republic, Egypt, Germany, Greece, India, Italy, Malaysia, Morocco, Netherlands, Nigeria, Poland, Portugal, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Thailand, Tunisia, United Kingdom, United States, Vietnam
The states and territories these words name
26 states and territories.
Every one of them
- Alaska
- Alabama
- California
- District of Columbia
- Florida
- Georgia
- Idaho
- Illinois
- Indiana
- Kentucky
- Louisiana
- Massachusetts
- Michigan
- Minnesota
- Mississippi
- North Carolina
- North Dakota
- New Jersey
- New York
- Ohio
- Pennsylvania
- Tennessee
- Texas
- Washington
- Wisconsin
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Dec 5, 2018.
- FDA classified it on Mar 30, 2019.
- FDA’s Enforcement Report published it on Apr 10, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Beckman Coulter Inc., of Brea, CA.
- 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 19,957 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.