| TGA Action ID |
RC-2026-RN-00641-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Clearview, Innovacon, InstAlert and Surestep hCG Tests. An in vitro diagnostic medical device (IVD).
Clearview hCG Combo Cassette (20/10 mIU/mL)
Part No: 92215
Clearview hCG Cassette (20 mIU/mL)
Part No: 92210
Clearview hCG Dipstick (25 mIU/mL)
Part No: 92211
Innovacon hCG One Step Pregnancy Test Device (Urine)
Part No: FHC-102
InstAlert hCG One Step Pregnancy Test Device (Urine)
Part No: FHC-102
Surestep hCG One Step Pregnancy Test Device (Urine)
Part No: FHC-102 |
| ARTG Number |
209317, 212966 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
As part of routine post-market surveillance activities, an investigation was conducted into reports of false-positive results and determined that while the tests demonstrate expected results at and above the established sensitivity levels, they may detect low levels of hCG below the stated assay sensitivity.
This may result in false positive test results in samples from non-pregnant individuals. |
| Instructions for Customers/Users |
Customers:
1. Until the IFU is updated, customers should read the updated IFU (labelled Kit Insert) in customer
2. Customer can minimise the risk of misinterpretation by the following:
- In situations where an unexpected test result is obtained, consider all limitations, including peri-menopause that may result in low levels of hCG.
- Note that a confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated, and an alternate confirmatory test that supports a timely clinical decision has been considered.
Distributors:
• Immediately quarantine any kits in your existing inventory.
• Arrange for certified destruction of kits in accordance with your local procedures and provide a certificate of destruction for the kits disposed of.
• Send the Urgent Product Correction Customer Letter to the end users (customers) |
| Action Commencement Date |
20/08/2026 |
| Responsible Entity |
|
| Contact Information |
1800 622 642 - Abbott Technical Services |