Product Recall for Abbott Pregnancy Tests

This notice is being provided to communicate that an investigation was conducted into false-positive reports for Clearview™/ Innovacon™/ InstAlert™/ Surestep™ hCG rapid tests and identified 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, which may result in a visible test line in samples from non-pregnant individuals.

As part of the investigation performed, one false positive result was observed in a sample with reported concentration as low as 3.939 mIU/mL for serum, no false positives were observed for urine specimens tested with concentrations ranging through 3.469 mIU/mL.

The current limitation is being updated to clarify that, in addition to the previously described conditions, low levels of hCG can occur naturally from the onset of peri-menopause. Therefore, the presence of hCG in urine or
serum specimens should not be used to diagnose pregnancy unless these conditions have been ruled out. This update will be incorporated in a future revision of the Instructions for Use (IFU).

As a reaffirmation, this test provides a presumptive diagnosis for pregnancy. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

There is no change to the test procedure when used according to the Instructions for Use. Abbott is continuing the investigation of this problem. Should further information become available as a result of ongoing investigations, appropriate communication will be provided to customers as warranted.

Please retain this notice with the product and ensure all testing and/or laboratory personnel are aware of this information. If you or any healthcare providers you serve have questions regarding this information, please contact Abbott Technical Service at 1800 622 642 (Australia), +61 7 3363 7711 (Pacific Islands) or 0800 466 951 (New Zealand).

Please take the following actions to minimise the risk of misinterpretation:

In situations where an unexpected test result is obtained, consider all limitations, including peri-menopause that may result in low levels of hCG.
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.

Following this, SSS Australia has made the decision to make these pregnancy tests temporarily unavailable until such time that the product correction has been completed. In the meantime, we have ranged the following pregnancy test as a direct alternative that are in stock and available for puchase now: East Test hCG Pregnancy Rapid Test

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Product Recall for Abbott Pregnancy Tests

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