Dimension Vista® Flex® reagent cartridge PROG 10461743Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · LOCI Progesterone Flex® reagent cartridge, 320 Tests · Class 1
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 00842768026478), received between Feb 18, 2021 and Feb 18, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “High 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.
Most reported problems
Device problems
- High 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.
MalfunctionFeb 18, 2021High Test Results; High Test Results
A DISCORDANT, FALSELY ELEVATED PROGESTERONE (PROG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 SYSTEM. THE RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON MULTIPLE LATER DATES AND SIMILAR RECOVERIES WERE OBTAINED. THE SAME SAMPLE WAS PROCESSED BY TWO ALTERNATE METHODOLOGIES AND LOWER, BELOW ASSAY RANGE RESULTS WERE OBTAINED. THE LOWER RESULTS WERE CONSIDERED CORRECT BY CUSTOMER, CONSISTENT WITH PATIENT HISTORY. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT PROGESTERONE RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11345928 ↗
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
- IMMULITE®/IMMULITE® 1000 Systems PRG Progesterone 10381128Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PROGESTERONE1 recall0 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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