Access Immunoassay Systems
Medical device recall Z-1257-2023. Published in FDA’s Enforcement Report on Mar 22, 2023.
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 22, 2023. 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
- 4,137 devices (990 U.S. and 3,147 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?
An increased incidence of damage to the nut band from a new vendor (Boamax) has led to an increased volume of complaints from consignees regarding wash arm motion failures, system check failures, and/or assay performance leading to a remote probability of delayed results or reporting erroneous patient results. The subject nut bands were found to not meet the firm’s specifications for hardness and had the incorrect material grain direction. Affected instruments were manufactured from December 28, 2017 to October 19, 2022 or had their nut bands replaced during the same period.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
4,137 devices (990 U.S. and 3,147 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI number for the Access 2 instruments: 15099590265380. No UDI for Access 2 Section, DxC 60i Packaged, Catalog #A25640. PN 81600N serial numbers: 570512 570513 570514 570515 570516 570517 570518 570519 570520 570521 570522 570523 570524…
Every code shown here, 1,995 characters
UDI number for the Access 2 instruments: 15099590265380. No UDI for Access 2 Section, DxC 60i Packaged, Catalog #A25640. PN 81600N serial numbers: 570512 570513 570514 570515 570516 570517 570518 570519 570520 570521 570522 570523 570524 570525 570526 570527 570528 570529 570530 570531 570532 570533 570534 570535 570536 570537 570538 570539 570540 570541 570542 570543 570544 570545 570546 570547 570548 570549 570550 570551 570552 570553 570554 570557 570559 570560 570562 570563 570564 570565 570566 570567 570568 570569 570570 570571 570572 570573 570574 570575 570576 570577 570578 570579 570580 570581 570582 570583 570584 570585 570586 570587 570588 570590 570591 570592 570593 570594 570598 570599 570600 570601 570602 570603 570604 570605 570606 570607 570608 570609 570610 570611 570612 570613 570614 570615 570616 570617 570618 570619 570620 570621 570622 570623 570624 570625 570626 570627 570628 570629 570630 570631 570632 570633 570634 570635 570636 570637 570638 570639 570640 570641 570642 570643 570644 570645 570646 570647 570648 570649 570650 570651 570652 570653 570654 570655 570656 570657 570658 570659 570660 570662 570664 570665 570666 570668 570669 570670 570671 570672 570673 570674 570677 570678 570679 570680 570681 570682 570683 570684 570685 570686 570687 570688 570689 570690 570691 570692 570693 570694 570695 570696 570697 570698 570699 570700 570701 570702 570703 570704 570705 570706 570707 570708 570709 570710 570711 570712 570713 570714 570715 570716 570717 570718 570719 570720 570721 570722 570723 570724 570725 570726 570727 570728 570729 570730 570731 570732 570733 570734 570735 570736 570737 570738 570740 570741 570742 570743 570744 570745 570746 570747 570748 570749 570750 570751 570752 570753 570754 570755 570756 570757 570758 570759 570760 570761 570763 570764 570765 570766 570768 570769 570770 570771 570772 570773 570774 570775 570776 570777 570778 570779 570780 570781 570782 570783 570784 570785 570786 570787 570788 570789 570790 570791…
FDA’s list runs to 29,159 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 and Nationwide Distribution. There was government/military distribution. Foreign distribution was made to Algeria, Andorra, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Bonaire, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, Lebanon, Libya, Lithuania, Macao, Malawi, Malaysia, Maldives, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, U.A.E, Uganda, Ukraine, United Kingdom, Uruguay, Vietnam, Yemen, Zambia, and Zimbabwe.
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, 2023.
- FDA classified it on Mar 15, 2023.
- FDA’s Enforcement Report published it on Mar 22, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Beckman Coulter, Inc., of Chaska, MN.
- 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 29,159 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.