Over 13 million pregnancy tests have been recalled around the world, including in the U.S., according to a little-noticed posting on the FDA’s website. The pregnancy tests, which were distributed to hospitals and not sold directly to consumers, can give a false positive.

Gizmodo first noticed a recall of pregnancy tests in Canada earlier this month, prompting us to look into whether any of the recalled tests were distributed to American hospitals. After some investigation, we have determined they were distributed in the U.S., but it’s one of those notices that didn’t get any attention in the American press when it was first issued.

The company that distributed the tests to hospitals is listed on the FDA’s website as Alere in San Diego, California, which is owned by healthcare giant Abbott. Two different representatives for Abbott initially seemed hesitant to answer our questions but eventually sent Gizmodo an on-the-record statement confirming the tests had been recalled in the U.S.

“Abbott initiated a field action in August for certain rapid pregnancy tests that are used only by healthcare professionals after learning that tests may detect low levels of hCG, a hormone produced during pregnancy, potentially resulting in false-positive results. Low levels of hCG can occur in some non-pregnant people, including at the onset of perimenopause,” the spokesperson wrote.

“We updated the product instructions and provided guidance to healthcare providers on how to handle unexpected results in people who may have low levels of detectable hCG. The impacted product does not need to be returned, and customers may continue to use the product,” the spokesperson’s statement continued.

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