Z-2426-2024.jsonld
type: Dataset
name: ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) " In vitro testing of samples of expired air for the parameters pO2 and pCO2 " In vitro testing of pleura samples for the pH parameter.
description: FDA recall Z-2426-2024 — Radiometer Medical ApS is recalling ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) " In vitro testing of samples of expired air for the parameters pO2 and pCO2 " In vitro testing of pleura samples for the pH parameter. (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: ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) " In vitro testing of samples of expired air for the parameters pO2 and pCO2 " In vitro testing of pleura samples for the pH parameter.
  manufacturer: Radiometer Medical ApS
claims: enforcement-record
claims: FDA classified recall Z-2426-2024 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2426-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2426-2024
      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: Radiometer Medical ApS
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-05-31
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: Model Numbers: 393-800 and 393-801 Part Numbers/Serial Numbers/UDI(-DI) codes: ABL825 754R0100N003 754R0100N003 ABL825 754R0241N010 754R0241N010 ABL825 754R0334N006 754R0334N006 ABL825 754R0417N008 754R0417N008 ABL825 754R0449N004 754R0449N004 ABL825 754R0487N004 754R0487N004 ABL837 754R0631N006 754R0631N006 ABL825 754R0755N003 754R0755N003 ABL825 754R0757N007 754R0757N007 ABL825 754R0884N007 754R0884N007 ABL825 754R0917N002 754R0917N002 ABL825 754R0918N007 754R0918N007 ABL810 754R0941N008 754R0941N008 ABL827 754R1001N004 (01)05700693938004(10)754R1001N004 ABL805 754R1028N005 754R1028N005 ABL825 754R1105N005 754R1105N005 ABL825 754R1157N006 754R1157N006 ABL825 754R1204N006 754R1204N006 ABL805 754R1209N005 754R1209N005 ABL825 754R1220N003 754R1220N003 ABL805 754R1222N005 754R1222N005 ABL805 754R1222N006 754R1222N006 ABL825 754R1222N009 754R1222N009 ABL825 754R1223N008 754R1223N008 ABL805 754R1226N007 754R1226N007 ABL825 754R1234N003 754R1234N003 ABL825 754R1238N009 754R1238N009 ABL825 754R1238N011 754R1238N011 ABL825 754R1239N007 754R1239N007 ABL825 754R1239N009 754R1239N009 ABL825 754R1239N010 754R1239N010 ABL820 754R1240N011 754R1240N011 ABL825 754R1261N006 754R1261N006 ABL825 754R1262N007 754R1262N007 ABL825 754R1266N006 754R1266N006 ABL825 754R1267N003 754R1267N003 ABL805 754R1291N003 754R1291N003 ABL835 754R1371N011 754R1371N011 ABL835 754R1377N002 754R1377N002 ABL827 754R1404N002 (01)05700693938004(10)754R1404N002 ABL825 754R1427N003 754R1427N003 ABL805 754R1427N007 754R1427N007 ABL805 754R1427N008 754R1427N008 ABL825 754R1428N001 754R1428N001 ABL825 754R1462N005 (01)05700693938004(10)754R1462N005 ABL825 754R1466N007 (01)05700693938004(10)754R1466N007 ABL837 754R1469N002 (01)05700693938004(10)754R1469N002 ABL825 754R1494N004 (01)05700693938004(10)754R1494N004 ABL805 754R1644N003 (01)05700693938004(10)754R1644N003 ABL825 754R1664N005 (01)05700693938004(10)754R1664N005 ABL825 754R1664N007 (01)05700693938004(10)754R1664N007 ABL827 754R1669N006 (01)05700693938004(1…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Canada, Afghanistan, Albania, Algeria, Argentina, Bahrain, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Cuba, Cyprus, Dominican Republic, Ecuador, Egypt, Eritrea, Ethiopia, Greece, Guatemala, Honduras, Iraq, Iran, Israel, Jamaica, Jordan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malta, Mauritius, Moldova, Nepal, Nicaragua, Nigeria, Oman, Pakistan, Paraguay, Peru, Philippines, Puerto Rico, Qatar, Romania, Saudi Arabia, Serbia, Slovenia, Sri Lanka, Suriname, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Uganda, Ukraine, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe Australia, New Zealand, New Caledonia, Tokelau, Austria, Belgium, Netherlands, China, Croatia, Czech Republic, Slovakia, Denmark, Iceland, Finland, Estonia, France, Germany, Hong Kong, Hungary, India, Brunei, Italy, Japan, Kazakhstan, Malaysia, Mexico, Norway, Poland, Russia, Singapore, South Africa, Cameroon, Ivory Coast, Malawi, South Korea, Spain, Portugal, Sweden, Switzerland, Turkey, United Kingdom, Ireland.
      status: recorded

enforcement-record
type: Claim
name: FDA recall Z-2426-2024: Radiometer Medical ApS is recalling ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) " In vitro testing of samples of expired air for the parameters pO2 and pCO2 " In vitro testing of pleura samples for the pH parameter.
text: The FDA logged enforcement record Z-2426-2024: Radiometer Medical ApS is voluntarily recalling ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) " In vitro testing of samples of expired air for the parameters pO2 and pCO2 " In vitro testing of pleura samples for the pH parameter. — reason: Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-31. Affected lots/codes: Model Numbers: 393-800 and 393-801 Part Numbers/Serial Numbers/UDI(-DI) codes: ABL825 754R0100N003 754R0100N003 ABL825 754R0241N010 754R0241N010 ABL825 754R0334N006 754R0334N006 ABL825 754R0417N008 754R0417N008 ABL825 754R0449N004 754R0449N004 ABL825 754R0487N004 754R0487N004 ABL837 754R0631N006 754R0631N006 ABL825 754R0755N003 754R0755N003 ABL825 754R0757N007 754R0757N007 ABL825 754R0884N007 754R0884N007 ABL825 754R0917N002 754R0917N002 ABL825 754R0918N007 754R0918N007 ABL810 754R0941N008 754R0941N008 ABL827 754R1001N004 (01)05700693938004(10)754R1001N004 ABL805 754R1028N005 754R1028N005 ABL825 754R1105N005 754R1105N005 ABL825 754R1157N006 754R1157N006 ABL825 754R1204N006 754R1204N006 ABL805 754R1209N005 754R1209N005 ABL825 754R1220N003 754R1220N003 ABL805 754R1222N005 754R1222N005 ABL805 754R1222N006 754R1222N006 ABL825 754R1222N009 754R1222N009 ABL825 754R1223N008 754R1223N008 ABL805 754R1226N007 754R1226N007 ABL825 754R1234N003 754R1234N003 ABL825 754R1238N009 754R1238N009 ABL825 754R1238N011 754R1238N011 ABL825 754R1239N007 754R1239N007 …
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-2426-2024 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.