Z-1257-2023.jsonld
type: Dataset
name: 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).
description: FDA recall Z-1257-2023 — Beckman Coulter, Inc. is recalling 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). (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
license: https://creativecommons.org/publicdomain/zero/1.0/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: MedicalDevice
  name: 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).
  manufacturer: Beckman Coulter, Inc.
claims: enforcement-record
claims: FDA classified recall Z-1257-2023 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1257-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1257-2023
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: Beckman Coulter, Inc.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: 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.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2023-01-26
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: 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 57079…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: 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.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-1257-2023: Beckman Coulter, Inc. is recalling 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).
text: The FDA logged enforcement record Z-1257-2023: Beckman Coulter, Inc. is voluntarily recalling 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). — reason: 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.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-01-26. Affected lots/codes: 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 …
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
falsifier: A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.

FDA classified recall Z-1257-2023 as Class II
type: Claim
text: The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
falsifier: occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.

What an FDA recall is — and is NOT
type: Claim
text: A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
falsifier: occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.