Access Thyroglobulin Calibrators 33865Recalls & reported problems
Beckman Coulter, Inc. · The Access Thyroglobulin Calibrators are intended to calibrate the Access Thyroglobulin assay for the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems. · Class 2
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Jul 6, 2023Open, Classified
It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11% in patient results.
Z-0100-2024 · Root cause: Other · FDA record ↗
Other System,Test,Thyroglobulin devices
- IMMULITE® 2000 Systems TG Thyroglobulin 10381647Siemens Healthcare Diagnostics Products Ltd · System,test,thyroglobulin1 recall8 reports
- Access Thyroglobulin 33860Beckman Coulter, Inc. · System,Test,Thyroglobulin1 recall4 reports
- Elecsys Tg II 08906564190Roche Diagnostics GmbH · System, test, thyroglobulin4 reports
- Elecsys Tg II 08906556160Roche Diagnostics GmbH · System, test, thyroglobulin1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.