T-4 Total ELISA EIA-4568Recalls & reported problems
DRG Instruments Gesellschaft mit beschränkter Haftung · The DRG T4 Total ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of total Thyroxin (T4) in serum or plasma (EDTA, lithium heparin or citrate plasma). · 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
- Jun 4, 2025Open, Classified
An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 instead of 2026-01-31). The expiration dates on the bottle labels were correct (i.e., 2026-01-31).
Z-2265-2025 · Root cause: Reprocessing Controls · Recall details · FDA record ↗
Other Radioimmunoassay, Total Thyroxine devices
- Elecsys T4 09007784190Roche Diagnostics GmbH · Radioimmunoassay, total thyroxine18 reports
- Elecsys T4 07027885190Roche Diagnostics GmbH · Radioimmunoassay, total thyroxine11 reports
- Elecsys T4 Assay 12017709122Roche Diagnostics GmbH · Radioimmunoassay, total thyroxine8 reports
- Elecsys T4 09007741190Roche Diagnostics GmbH · Radioimmunoassay, total thyroxine5 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
- 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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