STA Compact Max® 58990Recalls & reported problems
Diagnostica Stago · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03607450589900), received between Sep 13, 2019 and Sep 30, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 16, 2026.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2019
A LAB TECHNICIAN MANUALLY ENTERED AN INCORRECT RESULT FOR A PATIENT : 20.0 G/ML INSTEAD OF 0.37 G/ML. THE TECHNICIAN CONFUSED THE END PART OF THE NAME OF THE ASSAY "LIA-TEST DDI 20 G/ML" AS THE RESULT. CUSTOMER ACKNOWLEDGED THERE WAS NOTHING WRONG WITH THE ANALYZER. INSTRUCTIONS WERE GIVEN TO CUSTOMER TO CHANGE THE NAME OF THE TEST, TO AVOID CONFUSION. BASED UPON THE REPORTED RESULT THE PATIENT RECEIVED A CT ANGIOGRAM. THIS DID NOT RESULT IN ANY INJURY, IMPAIRMENT, OR DEATH TO THE PATIENT.
MAUDE report 9134172 ↗InjurySep 13, 2019Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem
A LAB TECHNICIAN MANUALLY ENTERED AN INCORRECT RESULT FOR A PATIENT: 20.0 ¿G/ML INSTEAD OF 0.37¿G/ML. THE TECHNICIAN CONFUSED THE END PART OF THE NAME OF THE ASSAY "LIA-TEST DDI 20 ¿G/ML" AS THE RESULT. CUSTOMER ACKNOWLEDGED THERE WAS NOTHING WRONG WITH THE ANALYZER. INSTRUCTIONS WERE GIVEN TO CUSTOMER TO CHANGE THE NAME OF THE TEST, TO AVOID CONFUSION. BASED UPON THE REPORTED RESULT THE PATIENT RECEIVED A CT ANGIOGRAM. THIS DID NOT RESULT IN ANY INJURY, IMPAIRMENT, OR DEATH TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 9046001 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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