Access Total T4 Calibrators 33805Recalls & reported problems
Beckman Coulter, Inc. · The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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 16, 2026.
Recalls naming this device
- Mar 16, 2026Open, Classified
Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.
Z-1922-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Other Calibrator, Primary devices
- ARCHITECT 2K43-25Abbott Ireland Diagnostics · CALIBRATOR, PRIMARY1 recall23 reports
- ARCHITECT 2K43-01Abbott Ireland Diagnostics · CALIBRATOR, PRIMARY1 recall10 reports
- VITROS 6802344Ortho-Clinical Diagnostics, Inc. · CALIBRATOR, PRIMARY1 recall0 reports
- ADVIA Centaur® Systems, ACS:180® Systems HCY Calibrator 10310376Siemens Healthcare Diagnostics Inc. · CALIBRATOR, PRIMARY1 recall0 reports
- VITROS 1112820Ortho Clinical Diagnostics · CALIBRATOR, PRIMARY1 recall0 reports
- HemosIL Heparin Calibrators 00020300600Instrumentation Laboratory Company · CALIBRATOR, PRIMARY1 recall0 reports
- Atellica IM HCY Calibrator 10995498Siemens Healthcare Diagnostics Inc. · Calibrator, primary1 recall0 reports
- ARCHITECT 6L27-01Abbott GmbH · CALIBRATOR, PRIMARY1 report
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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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