Elecsys Tg II 08906556160Recalls & reported problems
Roche Diagnostics GmbH · 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 07613336203569), received between Jun 20, 2024 and Jun 20, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Low Test Results” (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.
Reports received per month
Most reported problems
Device problems
- Low Test Results1
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.
MalfunctionJun 20, 2024Low Test Results; Low Test Results
THERE WAS AN ALLEGATION OF QUESTIONABLE ROCHE DIAGNOSTICS ELECSYS TG II RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E601 MODULE. THE INITIAL TG RESULT WAS 1.28 NG/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS >500 NG/ML. A 1:10 DILUTION WAS MADE OF THE SAMPLE AND REPEATED AND THE RESULT WAS 954.3 NG/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19576636 ↗
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
- Access Thyroglobulin Calibrators 33865Beckman Coulter, Inc. · System,Test,Thyroglobulin1 recall0 reports
- Elecsys Tg II 08906564190Roche Diagnostics GmbH · System, test, thyroglobulin4 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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