ARCHITECT 7K77-25Recalls & reported problems
Abbott Ireland · ARCHITECT Progesterone Reagent Kit (100T) · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740014919), received between Apr 21, 2021 and Apr 21, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Apr 24, 2025Open, Classified
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Z-1851-2025 · Root cause: Storage · FDA record ↗
Most reported problems
Device problems
- Leak/Splash1
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.
MalfunctionApr 21, 2021Leak/Splash; Leak/Splash
THE MALE USER OF THE ARCHITECT I1000SR REPORTED A SPLASH TO THE EYE WITH THE ARCHITECT PROGESTERONE CONTROL. HIS EYES WERE FLUSHED WITH WATER AND SALINE. THE USER WAS WEARING A LAB COAT AND GLOVES, BUT NOT EYE GOGGLES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11700441 ↗
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
- Alinity 08P3620Abbott Ireland · RADIOIMMUNOASSAY, PROGESTERONE1 recall1 report
- VIDAS® Progesterone 30409-01Biomerieux SA · RADIOIMMUNOASSAY, PROGESTERONE1 recall1 report
- 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
- IMMULITE 2000 Progesterone Kit Domestic 200T 10901873Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PROGESTERONE1 recall0 reports
- Atellica IM PRGE 10995659Siemens Healthcare Diagnostics Inc. · RADIOIMMUNOASSAY, PROGESTERONE16 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.