Abbott Recalls 13 Million Professional Pregnancy Tests
Healthcare providers must now use updated guidance to interpret results from these tests to avoid potential false positives.
Updated on Oct. 15, 2026 in Pregnancy
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Abbott recalled 13 million pregnancy tests on August 20, 2026, due to the potential for false-positive results. These professional-grade tests were distributed globally, including in the United States, Canada, and the United Kingdom.
Why it matters
The recall addresses a technical defect where tests may inaccurately detect low levels of human chorionic gonadotropin (hCG). This potential for false positives can lead to unnecessary clinical interventions or misinformed medical decisions for patients.
The recall encompasses 13 million units sold under brands including Fisher Scientific, McKesson, and Cardinal Health. While 2,800 units were confirmed sold to Canadian facilities, the tests do not need to be returned to the manufacturer.
The players
Abbott
A global healthcare company that develops medical devices and diagnostics with a history of international product recalls.
FDA
The United States regulatory agency responsible for protecting public health through the oversight of medical device recalls.
Fisher Scientific
A major distributor of laboratory equipment and clinical supplies often used by healthcare professionals.
The details
The tests are designed to detect hCG at a specific sensitivity level, but they can trigger false positives by reacting to lower levels of the hormone. Abbott updated instructions for healthcare providers to assist in interpreting unexpected results. Clinicians are advised to follow the updated protocols rather than returning the existing inventory.
Timeline
August 20, 2026: Abbott initiated the global recall of the affected pregnancy tests.
September 25, 2026: The FDA published the formal recall notice on its website.
October 2026: Gizmodo confirmed the distribution of the tests within the United States.
The Home Front
This recall reflects ongoing challenges in maintaining diagnostic accuracy across professional-grade point-of-care testing equipment. It underscores the importance of verifying test results with blood-based laboratory diagnostics when professional test outcomes are unexpected.
If you are a patient, remember that these tests were intended for professional healthcare use and not for home purchase. Always discuss any pregnancy test result with your doctor, who can confirm results with more definitive diagnostic tools.
The takeaway
Healthcare providers should follow the updated manufacturer guidance regarding test interpretation. If you have concerns about a test result, request a serum-based blood test from your healthcare provider for clinical confirmation.
Further reading
For more information on clinical testing standards, visit our Pregnancy section.
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