Abbott Recalls 13 Million Pregnancy Tests Worldwide
Healthcare providers are receiving updated instructions for interpreting results after a global recall of professional test kits.
Updated on Oct. 15, 2026 in Pregnancy
Live Poll
Do you trust the reliability of medical supplies currently used in your local healthcare facilities?
Abbott recalled 13 million pregnancy tests on August 20, 2026, due to a potential for false-positive results. The recall impacts professional-use diagnostic tests sold under brands like Fisher Scientific, McKesson, and Cardinal Health.
Why it matters
False-positive results in professional testing environments can lead to diagnostic confusion or unnecessary procedures for patients. This recall addresses those risks by updating interpretation guidelines for healthcare providers using these tests.
The recall involves 13 million pregnancy tests following reports that they may detect low levels of hCG and produce false-positive results. The FDA confirmed the recall notice on September 25, 2026, though specific frequency rates of these false positives remain under investigation.
The players
Abbott
A global healthcare company that develops diagnostics, medical devices, and nutritional products.
FDA
The United States agency responsible for protecting public health by ensuring the safety and efficacy of medical products.
The details
The affected tests are designed for healthcare professionals and may produce false-positive results if they detect low levels of human chorionic gonadotropin (hCG), a hormone typically associated with pregnancy. Abbott has updated product instructions to assist clinicians in interpreting results for patients who show low detectable hCG levels. Affected models are sold under several names, including Fisher Scientific, McKesson, and Cardinal Health, and do not need to be returned to the manufacturer.
Timeline
August 20, 2026: Abbott initiated the global recall of the pregnancy tests.
September 25, 2026: The FDA officially posted the recall notice on its website.
October 2026: Gizmodo confirmed the distribution of the tests within the United States.
Health Landscape
This action highlights the ongoing challenge of managing sensitivity thresholds in clinical diagnostics to avoid incidental findings. It underscores the critical role of updated clinical guidance in preventing diagnostic errors when test sensitivity exceeds physiological necessity.
If you are a patient, you should contact your primary care provider if you have questions about the results of a professional pregnancy test administered at a clinic. These recalled tests are restricted to professional use, meaning you should discuss any potential false-positive concerns with your physician.
The takeaway
Reliable testing depends on both the device and the correct interpretation of hormone levels by your clinical team. If you receive a positive test result that seems inconsistent with your history, schedule a follow-up conversation with your doctor to confirm the findings.
Further reading
For more information on diagnostic safety and testing accuracy, visit our Pregnancy section.
Source note: This article includes information reported by Gizmodo.
Live Poll
Do you trust the reliability of medical supplies currently used in your local healthcare facilities?
