| TGA Action ID |
RC-2026-RN-00651-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
VITROS Immunodiagnostic Products Anti-HAV Total Reagent Pack and Total Calibrator. An in vitro diagnostic medical device (IVD)
Catalogue Numbers: 6801461 and 6801462
Affected Lots: 6672, 6680, 6690, 6720, 6740, 6760
Expiry Dates: 15 August 2026, 15 September 2026, 10 October 2026, 1 December 2026, 5 January 2027, 27 January 2027 |
| ARTG Number |
266611 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
QuidelOrtho has confirmed that certain VITROS Immunodiagnostic Products Anti-HAV Total Reagent Packs and Total Calibrators may experience calibration or quality control (QC) failures.
QC may be affected in the following ways:
- For positive controls, this may cause results to shift to Borderline or Negative.
- For negative controls, this may cause results to shift to Borderline or Positive
Patient samples may be affected; however, investigation has not observed an impact on patient samples |
| Instructions for Customers/Users |
It is acceptable to continue using an affected lot of VITROS Anti-HAV Total Reagent Pack, provided your laboratory has successfully calibrated and generated acceptable QC results using the affected lot.
If your laboratory has experienced calibration and/or QC failures, discontinue using, render unusable, and discard the affected lot(s) of VITROS Anti-HAV Total Reagent Pack and associated lot of VITROS Anti-HAV Total Calibrator. QuidelOrtho will credit or replace your discarded inventory
QuidelOrtho does not recommend a review of previously reported results, as our investigation has not generated evidence that patient samples are affected by this problem.
The results of any diagnostic test should be evaluated in conjunction with a patient’s history, risk factors, clinical presentations, signs, and symptoms, as well as the results of other tests. |
| Action Commencement Date |
27/08/2026 |
| Responsible Entity |
|
| Contact Information |
1800 032 359 - Technical Services Center or mikaela.rasile@quidelortho.com |