Z-0680-2024.jsonld
type: Dataset
name: Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
description: FDA recall Z-0680-2024 — Abbott Laboratories is recalling Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples. (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: Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
  manufacturer: Abbott Laboratories
claims: enforcement-record
claims: FDA classified recall Z-0680-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0680-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0680-2024
      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: Abbott Laboratories
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2023-10-19
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: List Number: 03R65-01 Serial Numbers / UDI-DI codes (for U.S. systems only): AI01413 (01)00380740137366(21)AI01413 AI01414 (01)00380740137366(21)AI01414 AI01434 (01)00380740137366(21)AI01434 AI01447 (01)00380740137366(21)AI01447 AI01467 (01)00380740137366(21)AI01467 AI01468 (01)00380740137366(21)AI01468 AI01599 (01)00380740137366(21)AI01599 AI01607 (01)00380740137366(21)AI01607 AI01796 (01)00380740137366(21)AI01796 AI01823 (01)00380740137366(21)AI01823 AI01824 (01)00380740137366(21)AI01824 AI01827 (01)00380740137366(21)AI01827 AI01830 (01)00380740137366(21)AI01830 AI01837 (01)00380740137366(21)AI01837 AI01839 (01)00380740137366(21)AI01839 AI01873 (01)00380740137366(21)AI01873 AI01874 (01)00380740137366(21)AI01874 AI01991 (01)00380740137366(21)AI01991 AI02055 (01)00380740137366(21)AI02055 AI02056 (01)00380740137366(21)AI02056 AI02057 (01)00380740137366(21)AI02057 AI02058 (01)00380740137366(21)AI02058 AI02109 (01)00380740137366(21)AI02109 AI02110 (01)00380740137366(21)AI02110 AI02111 (01)00380740137366(21)AI02111 AI02117 (01)00380740137366(21)AI02117 AI02199 (01)00380740137366(21)AI02199 AI02201 (01)00380740137366(21)AI02201 AI02208 (01)00380740137366(21)AI02208 AI02232 (01)00380740137366(21)AI02232 AI02234 (01)00380740137366(21)AI02234 AI02288 (01)00380740137366(21)AI02288 AI02292 (01)00380740137366(21)AI02292 AI02293 (01)00380740137366(21)AI02293 AI02345 (01)00380740137366(21)AI02345 AI02368 (01)00380740137366(21)AI02368 AI02391 (01)00380740137366(21)AI02391 AI02392 (01)00380740137366(21)AI02392 AI02423 (01)00380740137366(21)AI02423 AI02433 (01)00380740137366(21)AI02433 AI02444 (01)00380740137366(21)AI02444 AI02448 (01)00380740137366(21)AI02448 AI02493 (01)00380740137366(21)AI02493 AI02514 (01)00380740137366(21)AI02514 AI02536 (01)00380740137366(21)AI02536 AI02555 (01)00380740137366(21)AI02555 AI02569 (01)00380740137366(21)AI02569 AI02592 (01)00380740137366(21)AI02592 AI02594 (01)00380740137366(21)AI02594 AI02595 (01)00380740137366(21)AI02595 AI02750 (01)00380740137…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: U.S.: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV O.U.S.: Brazil
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-0680-2024: Abbott Laboratories is recalling Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
text: The FDA logged enforcement record Z-0680-2024: Abbott Laboratories is voluntarily recalling Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples. — reason: The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).. Status: Ongoing — the recall is still being carried out.. Initiated 2023-10-19. Affected lots/codes: List Number: 03R65-01 Serial Numbers / UDI-DI codes (for U.S. systems only): AI01413 (01)00380740137366(21)AI01413 AI01414 (01)00380740137366(21)AI01414 AI01434 (01)00380740137366(21)AI01434 AI01447 (01)00380740137366(21)AI01447 AI01467 (01)00380740137366(21)AI01467 AI01468 (01)00380740137366(21)AI01468 AI01599 (01)00380740137366(21)AI01599 AI01607 (01)00380740137366(21)AI01607 AI01796 (01)00380740137366(21)AI01796 AI01823 (01)00380740137366(21)AI01823 AI01824 (01)00380740137366(21)AI01824 AI01827 (01)00380740137366(21)AI01827 AI01830 (01)00380740137366(21)AI01830 AI01837 (01)00380740137366(21)AI01837 AI01839 (01)00380740137366(21)AI01839 AI01873 (01)00380740137366(21)AI01873 AI01874 (01)00380740137366(21)AI01874 AI01991 (01)00380740137366(21)AI01991 AI02055 (01)00380740137366(21)AI02055 AI02056 (01)00380740137366(21)AI02056 AI02057 (01)00380740137366(21)AI02057 AI02058 (01)00380740137366(21)AI02058 AI02109 (01)00380740137366(21)AI02109 AI02110 (01)00380740137366(21)AI02110 AI02111 (01)00380740137366(21)AI02111 AI02117 (01)00380740137366(21)AI02117 AI02199 (01)00380740137366(21)AI02199 AI02201 (01)00380740137366(21)AI02201 AI02208 (01)00380740137366(21)AI02208 AI02232 (01)00380740137366(21)AI02232 AI02234 (01)00380740137366(21)AI02234 AI02288 (01)00380740137366(21)AI02288 AI0…
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-0680-2024 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.