IMMULITE®/IMMULITE® 1000 Systems PRG Progesterone 10381128Recalls & reported problems
Siemens Healthcare Diagnostics Products Ltd · Progesterone - IMMULITE - RGT - 100 tests · Class 1
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
- Jul 10, 2019Class IITerminated
There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation.
Z-2289-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other RADIOIMMUNOASSAY, PROGESTERONE devices
- IMMULITE® 2000 Systems PRG Progesterone 10381181Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PROGESTERONE1 recall4 reports
- IMMULITE® 2000 Systems PRG Progesterone 10381170Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PROGESTERONE1 recall3 reports
- ARCHITECT 7K77-25Abbott Ireland · RADIOIMMUNOASSAY, PROGESTERONE1 recall1 report
- Alinity 08P3620Abbott Ireland · RADIOIMMUNOASSAY, PROGESTERONE1 recall1 report
- VIDAS® Progesterone 30409-01Biomerieux SA · RADIOIMMUNOASSAY, PROGESTERONE1 recall1 report
- IMMULITE 2000 Progesterone Kit Domestic 200T 10901873Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PROGESTERONE1 recall0 reports
- IMMULITE 2000 Progesterone Kit Domestic 600T 10901874Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PROGESTERONE1 recall0 reports
- Atellica IM PRGE 10995659Siemens Healthcare Diagnostics Inc. · RADIOIMMUNOASSAY, PROGESTERONE16 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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