Z-2616-2024.jsonld
type: Dataset
name: BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
description: FDA recall Z-2616-2024 — Biointellisense Inc. is recalling BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. (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: BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
  manufacturer: Biointellisense Inc.
claims: enforcement-record
claims: FDA classified recall Z-2616-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2616-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2616-2024
      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: Biointellisense Inc.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-07-19
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: Part Number: BIOST06040 UDI-DI code: 00850005949299 UDI code/Lot Number /BioID: U.S. 01008500059492991095422964 95422964 1897-529-643 01008500059492991095422964 95422964 2273-984-549 01008500059492991095422964 95422964 2353-391-610 01008500059492991095422964 95422964 1983-418-284 01008500059492991095422964 95422964 2197-213-247 01008500059492991095422964 95422964 2195-552-499 01008500059492991095422964 95422964 0776-970-222 01008500059492991095422964 95422964 0759-262-015 01008500059492991095422964 95422964 0693-068-049 01008500059492991095422964 95422964 1037-592-544 01008500059492991095422964 95422964 0586-886-801 01008500059492991095422964 95422964 0725-951-385 01008500059492991095422964 95422964 2837-953-215 01008500059492991095422964 95422964 1908-223-951 01008500059492991095422964 95422964 1564-661-854 01008500059492991095422964 95422964 1371-357-677 01008500059492991095422964 95422964 1491-596-810 01008500059492991095422964 95422964 1300-630-104 01008500059492991095422964 95422964 1497-784-550 01008500059492991095422964 95422964 1304-916-970 01008500059492991095422964 95422964 1690-284-987 01008500059492991095422964 95422964 1387-183-307 01008500059492991095422964 95422964 1691-252-142 01008500059492991095422964 95422964 2837-106-528 01008500059492991095422964 95422964 2841-866-964 01008500059492991095422964 95422964 2467-553-052 01008500059492991095422964 95422964 2436-514-105 01008500059492991095422964 95422964 1716-554-425 01008500059492991095422964 95422964 1749-713-834 01008500059492991095422964 95422964 1750-319-768 01008500059492991095422964 95422964 3218-162-830 01008500059492991095422964 95422964 3375-451-062 01008500059492991095422964 95422964 3458-102-837 01008500059492991095422964 95422964 3451-172-426 01008500059492991095422964 95422964 3459-644-173 01008500059492991095422964 95422964 3535-383-398 01008500059492991095422964 95422964 0065-120-297 01008500059492991095422964 95422964 2663-792-243 01008500059492991095422964 95422964 2851-670-555 0100…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: U.S.: CA, CO, MA, TN, and TX O.U.S.: not provided
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-2616-2024: Biointellisense Inc. is recalling BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
text: The FDA logged enforcement record Z-2616-2024: Biointellisense Inc. is voluntarily recalling BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. — reason: Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-07-19. Affected lots/codes: Part Number: BIOST06040 UDI-DI code: 00850005949299 UDI code/Lot Number /BioID: U.S. 01008500059492991095422964 95422964 1897-529-643 01008500059492991095422964 95422964 2273-984-549 01008500059492991095422964 95422964 2353-391-610 01008500059492991095422964 95422964 1983-418-284 01008500059492991095422964 95422964 2197-213-247 01008500059492991095422964 95422964 2195-552-499 01008500059492991095422964 95422964 0776-970-222 01008500059492991095422964 95422964 0759-262-015 01008500059492991095422964 95422964 0693-068-049 01008500059492991095422964 95422964 1037-592-544 01008500059492991095422964 95422964 0586-886-801 01008500059492991095422964 95422964 0725-951-385 01008500059492991095422964 95422964 2837-953-215 01008500059492991095422964 95422964 1908-223-951 01008500059492991095422964 95422964 1564-661-854 01008500059492991095422964 95422964 1371-357-677 01008500059492991095422964 95422964 1491-596-810 01008500059492991095422964 95422964 1300-630-104 01008500059492991095422964 95422964 1497-784-550 01008500059492991095422964 95422964 1304-916-970 01008500059492991095422964 95422964 1690-284-987 01008500059492991095422964 95422964 1387-183-307 01008500059492991095422964 95422964 1691-252-142 01008500059492991095422964 95422964 2837-106-528 01008500059492991095422964 95422964 2841-866-964 01008500059492991095422964 95422964 2467-553-052 01008500059492991095422964 95422964 2436-514-105 01008500059492991095422964 95422964 1716-554-425 0…
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-2616-2024 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.