ST AIA-PACK PROG II N/ARecalls & reported problems
Tosoh Corporation · Class 2
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 14560189213392), received between Dec 9, 2021 and Dec 9, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Ingredient or Reagent Problem” (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
- Device Ingredient or Reagent Problem1
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.
MalfunctionDec 9, 2021Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem
THE CUSTOMER REPORTED A DISCREPANT RESULT FOR PROGESTERONE II (PROGII) SAMPLE ON THE AIA-360 ANALYZER. THE RESULT WAS 3.55NG/ML AND THE PHYSICIAN QUESTIONED THE RESULT; THE PATIENT SAMPLE WAS SENT TO A REFERENCE LAB FOR COMPARISON AND RESULT WAS 1.5NG/ML. THE SPECIMEN WAS REPEATED ON THE AIA-360 AND RESULT WAS STILL CONSISTENT AROUND 3.0NG/ML. A NEW SPECIMEN WAS DRAWN THE NEXT DAY AND THE AIA-360 RESULT WAS 1.8NG/ML. THE TECHNICAL SUPPORT SPECIALIST (TSS) EXPLAINED THERE IS A DIFFERENCE IN MANUFACTURER'S RANGES AND INTERPRETATION. REFERENCE LAB RANGES ARE: FOLLICULAR - 0.1-0.9; LUTEAL - 1.8-23.9; OVULATION - 0.1-12.0. TOSOH'S RANGES ARE: FOLLICULAR - </= 2.05; LUTEAL - </= 22.65; OVULATION - </= 19.56. TSS CONFIRMED THE SPECIMEN WAS DRAWN IN AN SST TUBE, CLOTTED FOR 30 MIN AND SPUN 5 - 10 MIN. THE SPECIMEN WAS NOT POURED OFF. THE CUSTOMER CONFIRMED QUALITY CONTROL AND CALIBRATION RUN RESULTS WERE ALL IN RANGE. TSS SENT PROGESTERONE III (PROGIII) REAGENTS TO THE CUSTOMER TO EVALUATE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER¿S SITE TO FURTHER INVESTIGATION. THERE WAS NO INDICATION OF ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVEN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12972943 ↗
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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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