Summary
A fault affecting one HbA1c analyser may have caused a small number of spurious HbA1c results. Clinicians should consider repeat testing when results are unexpected or inconsistent with the clinical picture.
Background
Pathlab has identified an analytical issue affecting one HbA1c analyser. The issue was identified due to a clinician following up on an unexpected HbA1c result. Investigations have determined that the issue was caused by sample carryover during specimen dispensing. The implicated analyser was immediately removed from service on 9 October 2026.
This error was not detectable by daily internal quality control measures. As such, it is difficult to determine the exact starting date of the problem. From investigations so far, it likely started on or before 29th September 2026.
Impact on HbA1c Results
Based on the available data, 0.56% of all HbA1c samples may have been affected. Most differences observed between repeats were modest and within acceptable laboratory error allowances (less than 10% difference). For a small proportion of samples, however, larger discrepancies between repeat results were observed (greater than 20%), in either direction (higher or lower), including some results that crossed clinical decision thresholds.
Clinical Guidance
Clinicians are advised to exercise caution when interpreting HbA1c results and to carefully correlate with historical results and the patient’s overall clinical picture. Where there is clinical concern, repeat HbA1c testing is recommended before initiating or substantially altering treatment.
Further Information
Pathlab is continuing to investigate to try to determine the extent of this problem and any other quality improvements that can be made. A further review of results will focus on patients with no historical HbA1c results with which to compare.
If any patient or clinician is concerned about a reported HbA1c result being potentially erroneous, please request repeat HbA1c testing at no additional cost (if payment is usually applicable).
If you have concerns regarding a patient’s HbA1c result or wish to discuss the need for repeat testing, please contact Pathlab via their online contact form. Please include patient NHI and/or Pathlab request number.
Pathlab sincerely apologises for this situation and the effect it has on our patients.