Trinity Biotech HbA1c (GHb) Controls Kit, 500uL (Levels I & II) - 1 kitRecalls & reported problems
Primus Corporation · Hemoglobin A1c assay, HbA1c (GHb) Controls Kit, 500uL (Levels I & II) - 1 kit · 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 05391516748087), received between Nov 16, 2021 and Nov 16, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unable to Obtain Readings” (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
- Unable to Obtain Readings1
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.
MalfunctionNov 16, 2021Unable to Obtain Readings; Unable to Obtain Readings
HBA1C CONTROL I OF LOT 12160 OBSERVED WITH VALUES ABOVE THE ACCEPTABLE TARGET RANGE. VENDOR IDENTIFIED AN UNCOMMONLY HIGH GLUCOSE LEVEL IN THE CONTROL MATERIAL WHICH GLYCATES OVER TIME CREATED FALSE HIGH VALUES. PRODUCT LOT HAD BEEN PLACED ON SHIPPING HOLD NEAR THE SAME TIME AS THE COMPLAINT. NO KNOWN REPORTING TO MEDICAL STAFF OR PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12819907 ↗
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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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