Disposable Waste Container D513 REF 905-802Recalls & reported problems
Radiometer Medical ApS · D513 Disposable waste container 600mL, for ABL8XX FLEX · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05700699058027), received between Apr 1, 2022 and Apr 1, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2022Infusion or Flow Problem; Infusion or Flow Problem
ACCORDING TO THE COMPLAINT THE CUSTOMER COULD OBSERVE A PRESSURIZED WASTE CONTAINER. THE CUSTOMER FOUND THE BOTTOM LEFT COVER LIFTING OFF THE ABL800 FLEX ANALYZER BECAUSE IT WAS BEING PROPPED UP BY A BULGING WASTE BOTTLE. THE BOTTLE LOT NUMBER IS ML54 MANUFACTURED ON 14-01-2022. IT WAS UNDER SO MUCH PRESSURE THE BULGING BOTTLE WAS PREVENTING THE LID FROM BEING HELD DOWN BY THE MAGNETS AND IT KEPT FALLING OFF AND WOULD NOT STAY ON. THE WASTE CONSISTS OF BLOOD AND USED QC AND CALIBRATION LIQUID AND IF THE WASTE CONTAINER IS INFLATED, THERE IS A RISK OF WASTE SQUIRTING OUT OF THE CONTAINER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13974890 ↗
Other DIAZO COLORIMETRY, BILIRUBIN devices
- Dimension® Flex® reagent cartridge TBI 10444957Siemens Healthcare Diagnostics Inc. · DIAZO COLORIMETRY, BILIRUBIN2 recalls4 reports
- Dimension Vista® Flex® reagent cartridge TBIL 10445146Siemens Healthcare Diagnostics Inc. · DIAZO COLORIMETRY, BILIRUBIN1 recall7 reports
- VITROS 8383051Ortho-Clinical Diagnostics, Inc. · DIAZO COLORIMETRY, BILIRUBIN1 recall5 reports
- VITROS 1612365Ortho-Clinical Diagnostics, Inc. · DIAZO COLORIMETRY, BILIRUBIN1 recall1 report
- ARCHITECT 6L45-21Abbott Laboratories · DIAZO COLORIMETRY, BILIRUBIN46 reports
- ARCHITECT 6L45-22Abbott GmbH · DIAZO COLORIMETRY, BILIRUBIN30 reports
- ARCHITECT 6L45-41Abbott Laboratories · DIAZO COLORIMETRY, BILIRUBIN18 reports
- Bilirubin Direct Gen.2 08056951190Roche Diagnostics GmbH · DIAZO COLORIMETRY, BILIRUBIN17 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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