Z-0681-2024.jsonld
type: Dataset
name: Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c Processing Module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c Processing Module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).
description: FDA recall Z-0681-2024 — Abbott Laboratories is recalling Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c Processing Module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c Processing Module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes). (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 c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c Processing Module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c Processing Module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).
  manufacturer: Abbott Laboratories
claims: enforcement-record
claims: FDA classified recall Z-0681-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0681-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0681-2024
      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: 03R67-01 Serial Numbers / UDI-DI codes (U.S. systems): AC01225 (01)00380740137380(21)AC01225 AC01226 (01)00380740137380(21)AC01226 AC01256 (01)00380740137380(21)AC01256 AC01257 (01)00380740137380(21)AC01257 AC01263 (01)00380740137380(21)AC01263 AC01264 (01)00380740137380(21)AC01264 AC01273 (01)00380740137380(21)AC01273 AC01274 (01)00380740137380(21)AC01274 AC01275 (01)00380740137380(21)AC01275 AC01356 (01)00380740137380(21)AC01356 AC01357 (01)00380740137380(21)AC01357 AC01358 (01)00380740137380(21)AC01358 AC01503 (01)00380740137380(21)AC01503 AC01504 (01)00380740137380(21)AC01504 AC01505 (01)00380740137380(21)AC01505 AC01506 (01)00380740137380(21)AC01506 AC01507 (01)00380740137380(21)AC01507 AC01508 (01)00380740137380(21)AC01508 AC01509 (01)00380740137380(21)AC01509 AC01510 (01)00380740137380(21)AC01510 AC01512 (01)00380740137380(21)AC01512 AC01513 (01)00380740137380(21)AC01513 AC01518 (01)00380740137380(21)AC01518 AC01521 (01)00380740137380(21)AC01521 AC01522 (01)00380740137380(21)AC01522 AC01523 (01)00380740137380(21)AC01523 AC01553 (01)00380740137380(21)AC01553 AC01554 (01)00380740137380(21)AC01554 AC01561 (01)00380740137380(21)AC01561 AC01566 (01)00380740137380(21)AC01566 AC01582 (01)00380740137380(21)AC01582 AC01584 (01)00380740137380(21)AC01584 AC01585 (01)00380740137380(21)AC01585 AC01588 (01)00380740137380(21)AC01588 AC01589 (01)00380740137380(21)AC01589 AC01591 (01)00380740137380(21)AC01591 AC01593 (01)00380740137380(21)AC01593 AC01594 (01)00380740137380(21)AC01594 AC01603 (01)00380740137380(21)AC01603 AC01604 (01)00380740137380(21)AC01604 AC01605 (01)00380740137380(21)AC01605 AC01606 (01)00380740137380(21)AC01606 AC01608 (01)00380740137380(21)AC01608 AC01630 (01)00380740137380(21)AC01630 AC01644 (01)00380740137380(21)AC01644 AC01666 (01)00380740137380(21)AC01666 AC01667 (01)00380740137380(21)AC01667 AC01668 (01)00380740137380(21)AC01668 AC01669 (01)00380740137380(21)AC01669 AC01670 (01)00380740137380(21)AC01670 AC01671 (01)00380740137380(21)AC…
      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-0681-2024: Abbott Laboratories is recalling Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c Processing Module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c Processing Module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).
text: The FDA logged enforcement record Z-0681-2024: Abbott Laboratories is voluntarily recalling Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c Processing Module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c Processing Module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes). — 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: 03R67-01 Serial Numbers / UDI-DI codes (U.S. systems): AC01225 (01)00380740137380(21)AC01225 AC01226 (01)00380740137380(21)AC01226 AC01256 (01)00380740137380(21)AC01256 AC01257 (01)00380740137380(21)AC01257 AC01263 (01)00380740137380(21)AC01263 AC01264 (01)00380740137380(21)AC01264 AC01273 (01)00380740137380(21)AC01273 AC01274 (01)00380740137380(21)AC01274 AC01275 (01)00380740137380(21)AC01275 AC01356 (01)00380740137380(21)AC01356 AC01357 (01)00380740137380(21)AC01357 AC01358 (01)00380740137380(21)AC01358 AC01503 (01)00380740137380(21)AC01503 AC01504 (01)00380740137380(21)AC01504 AC01505 (01)00380740137380(21)AC01505 AC01506 (01)00380740137380(21)AC01506 AC01507 (01)00380740137380(21)AC01507 AC01508 (01)00380740137380(21)AC01508 AC01509 (01)00380740137380(21)AC01509 AC01510 (01)00380740137380(21)AC01510 AC01512 (01)00380740137380(21)AC01512 AC01513 (01)00380740137380(21)AC01513 AC01518 (01)00380740137380(21)AC01518 AC01521 (01)00380740137380(21)AC01521 AC01522 (01)00380740137380(21)AC01522 AC0152…
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-0681-2024 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.