OFFICIAL-SOURCE RECALL · AUSTRALIA
Clearview, Innovacon, InstAlert and Surestep hCG Tests. An in vitro Recall: Classification Class II Reason
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Is your product affected?
- Brand
- See official notice
- Product
- Clearview, Innovacon, InstAlert and Surestep hCG Tests. An in vitro diagnostic medical device (IVD).
- Manufacturer
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- Lot number
- numbers
- Batch number
- numbers
- Date code
- dates
- Expiration date
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The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
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 loc
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 loc
Official recall notice
Clearview, Innovacon, InstAlert and Surestep hCG Tests. An in vitro diagnostic medical device (IVD).
Agency: Therapeutic Goods Administration
Official publication date: August 20, 2026
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