Z-0682-2024.jsonld
type: Dataset
name: ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
description: FDA recall Z-0682-2024 — Abbott Laboratories is recalling ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. (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: ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
  manufacturer: Abbott Laboratories
claims: enforcement-record
claims: FDA classified recall Z-0682-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0682-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0682-2024
      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: 02P24-01 Serial Numbers / UDI Codes: C400911 (01)00380740003746(21)C400911 C402913 (01)00380740003746(21)C402913 C460004 (01)00380740003746(21)C460004 C460033 (01)00380740003746(21)C460033 C460055 (01)00380740003746(21)C460055 C460066 (01)00380740003746(21)C460066 C460082 (01)00380740003746(21)C460082 C460158 (01)00380740003746(21)C460158 C460200 (01)00380740003746(21)C460200 C460375 (01)00380740003746(21)C460375 C460385 (01)00380740003746(21)C460385 C460396 (01)00380740003746(21)C460396 C460397 (01)00380740003746(21)C460397 C460408 (01)00380740003746(21)C460408 C460410 (01)00380740003746(21)C460410 C460422 (01)00380740003746(21)C460422 C460435 (01)00380740003746(21)C460435 C460439 (01)00380740003746(21)C460439 C460523 (01)00380740003746(21)C460523 C460532 (01)00380740003746(21)C460532 C460588 (01)00380740003746(21)C460588 C460728 (01)00380740003746(21)C460728 C460767 (01)00380740003746(21)C460767 C460797 (01)00380740003746(21)C460797 C460798 (01)00380740003746(21)C460798 C460800 (01)00380740003746(21)C460800 C460826 (01)00380740003746(21)C460826 C460827 (01)00380740003746(21)C460827 C460830 (01)00380740003746(21)C460830 C460832 (01)00380740003746(21)C460832 C460833 (01)00380740003746(21)C460833 C460834 (01)00380740003746(21)C460834 C460846 (01)00380740003746(21)C460846 C460849 (01)00380740003746(21)C460849 C460857 (01)00380740003746(21)C460857 C460868 (01)00380740003746(21)C460868 C460875 (01)00380740003746(21)C460875 C460886 (01)00380740003746(21)C460886 C460927 (01)00380740003746(21)C460927 C460928 (01)00380740003746(21)C460928 C460939 (01)00380740003746(21)C460939 C460958 (01)00380740003746(21)C460958 C460993 (01)00380740003746(21)C460993 C461042 (01)00380740003746(21)C461042 C461092 (01)00380740003746(21)C461092 C461093 (01)00380740003746(21)C461093 C461100 (01)00380740003746(21)C461100 C461105 (01)00380740003746(21)C461105 C461112 (01)00380740003746(21)C461112 C461122 (01)00380740003746(21)C461122 C461124 (01)00380740003746(21)C461124 C461129 (01)…
      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-0682-2024: Abbott Laboratories is recalling ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
text: The FDA logged enforcement record Z-0682-2024: Abbott Laboratories is voluntarily recalling ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. — 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: 02P24-01 Serial Numbers / UDI Codes: C400911 (01)00380740003746(21)C400911 C402913 (01)00380740003746(21)C402913 C460004 (01)00380740003746(21)C460004 C460033 (01)00380740003746(21)C460033 C460055 (01)00380740003746(21)C460055 C460066 (01)00380740003746(21)C460066 C460082 (01)00380740003746(21)C460082 C460158 (01)00380740003746(21)C460158 C460200 (01)00380740003746(21)C460200 C460375 (01)00380740003746(21)C460375 C460385 (01)00380740003746(21)C460385 C460396 (01)00380740003746(21)C460396 C460397 (01)00380740003746(21)C460397 C460408 (01)00380740003746(21)C460408 C460410 (01)00380740003746(21)C460410 C460422 (01)00380740003746(21)C460422 C460435 (01)00380740003746(21)C460435 C460439 (01)00380740003746(21)C460439 C460523 (01)00380740003746(21)C460523 C460532 (01)00380740003746(21)C460532 C460588 (01)00380740003746(21)C460588 C460728 (01)00380740003746(21)C460728 C460767 (01)00380740003746(21)C460767 C460797 (01)00380740003746(21)C460797 C460798 (01)00380740003746(21)C460798 C460800 (01)00380740003746(21)C460800 C460826 (01)00380740003746(21)C460826 C460827 (01)00380740003746(21)C460827 C460830 (01)00380740003746(21)C460830 C460832 (01)00380740003746(21)C460832 C460833 (01)00380740003746(21)C460833 C460834 (01)00380740003746(21)C460834 C460846 (01)00380740003746(21)C460846 C460849 (01)00380740003746(21)C460849 C460857 (01)00380740003746(21)C460857 C460868 (01)00380740003746(21)C460868 C460875 (01)003807400…
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-0682-2024 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.