ARCHITECT 8K27-25Recalls & reported problems
Abbott GmbH · ARCHITECT DHEA-S Reagent Kit · Class 1
All models of ARCHITECT (48)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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.
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.
Recalls naming this device
- Dec 14, 2017Class IITerminated
Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old.
Z-1629-2018 · Root cause: Device Design · Recall details · FDA record ↗
Other RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE) devices
- Elecsys DHEA-S 07027192190Roche Diagnostics GmbH · RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE)12 reports
- Elecsys DHEA-S 3000087122Roche Diagnostics GmbH · RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE)2 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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