It started with a quiet posting on the Food and Drug Administration’s website—the kind of notice that rarely makes headlines, and the kind that can easily slip through the cracks of an overwhelmed news cycle. But for the people affected, the stakes were anything but quiet. More than 13 million pregnancy tests have been recalled around the world, including in the United States. These are not the over-the-counter sticks you buy at a pharmacy and pee on in the privacy of your own bathroom. These are professional-grade tests used in hospitals and clinics, handled by doctors, nurses, and lab technicians. And they are being recalled because they can produce a false positive—a result that says “yes, you are pregnant” when, in fact, you are not. Imagine the emotional whiplash. A patient already nervous in a hospital setting is told they are pregnant, only to later discover the test was wrong. Or imagine a doctor relying on a positive result to guide urgent medical decisions, not realizing the test may be misleading. That is the human reality behind this recall, and it’s why this story deserves far more attention than it received.
The recall was first flagged by Gizmodo after they noticed a pregnancy test recall in Canada earlier this month. That prompted a deeper look into whether the same tests had made their way into American hospitals. After some investigation, it became clear that yes, they had. The company listed on the FDA’s website as the distributor is Alere, based in San Diego, California, which is owned by the healthcare giant Abbott. At first, representatives for Abbott seemed hesitant to answer questions. But eventually, the company issued an on-the-record statement confirming the recall in the U.S. According to Abbott, the recall was a “field action” initiated in August for certain rapid pregnancy tests used only by healthcare professionals. The problem? The 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. In other words, the very sensitivity that makes these tests useful—their ability to spot tiny amounts of a hormone—also makes them prone to overreacting in bodies where hCG appears for reasons unrelated to pregnancy.
Abbott’s response was careful and measured. The company said it 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. Importantly, the impacted product does not need to be returned, and customers may continue to use the product. That may sound reassuring on paper, but it also raises questions. If a test can produce a false positive, how comfortable should a provider feel continuing to use it? The company’s guidance is essentially: keep using the test, but be cautious if you see an unexpected positive result, especially in someone who might have low hCG levels. That is a nuanced and somewhat complicated message. In a busy hospital, with staff stretched thin and patients waiting, nuance can be lost. A positive pregnancy test often triggers a cascade of next steps: further blood work, ultrasounds, counseling, changes to medications, and difficult conversations. If a test is known to be unreliable in certain populations, shouldn’t it be pulled from shelves entirely? Abbott insists that no return is needed, and that updated labeling will help. But for the patients who receive a false positive before those updated instructions reach every clinician, the emotional and medical consequences can be significant.
Gizmodo asked several times over the past week how many of the 13 million recalled tests were distributed in the U.S., but they didn’t receive a response. That lack of transparency is troubling. The recall is global in scope. According to the FDA notice, the tests were distributed not only in the United States, but also in the United Kingdom, Canada, Italy, Ireland, Spain, Portugal, New Zealand, Hong Kong, Australia, Papua New Guinea, Fiji, Guam, and Sweden. That is a staggering list of countries, spanning continents and affecting healthcare systems of all sizes. In smaller nations like Fiji or Papua New Guinea, a recall notice from a distant regulator might take even longer to reach frontline clinicians. And in places where diagnostic resources are scarce, a false positive could be even more damaging—leading to unnecessary procedures, delayed diagnoses, or emotional trauma in communities where pregnancy carries deep personal and social significance. The fact that these tests are sold under many different brand names makes the recall even harder to track. A hospital might not realize the box in their supply closet is part of a global recall if the label doesn’t say “Alere” or “Abbott.” It’s a reminder that medical devices and diagnostics are often repackaged, rebranded, and distributed through complex supply chains, making recalls messy and difficult to communicate.
A spokesperson for Health Canada confirmed to Gizmodo that the pregnancy tests had been recalled in Canada by a company called Innovacon, Inc., also based in San Diego. In Canada, approximately 2,800 affected units were sold to healthcare facilities. The device is intended for professional use only, and healthcare professionals may continue to use the device, but should consider low hCG levels when interpreting results. The recalled tests were sold under a variety of names, according to the FDA, including Fisher Scientific Sure-Vue Urine hCG Strip, McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Henry Schein One Step+ hCG Urine Strip Test, Alere hCG Dipstick (25mIU/mL) in Urine, Cardinal Health hCG Dipstick Rapid Test CLIA Waived, Medline hCG Pregnancy Test Strip, and Pro Advantage by NDC Urine Pregnancy Test Strip. For anyone who works in healthcare, these names are familiar. Fisher Scientific, McKesson, Cardinal Health, Henry Schein, Medline—these are household names in the medical supply world, trusted distributors that hospitals rely on every day. Seeing a recall attached to those names makes the issue feel closer to home. It’s not some obscure generic product; it’s the brand your hospital orders from, the one with the familiar logo on the box. The model number FHC-101 appears across all of them, suggesting a common underlying test manufactured for multiple companies. That means the problem is not specific to one brand’s labeling or packaging, but rather the test itself.
The timeline of the recall is also worth pausing over. The recall was initiated on August 20, but the notice wasn’t posted on the FDA’s website until September 25. That’s more than a month in between. During that time, hospitals may have continued using the tests without any updated instructions. And even after the FDA posting, the mainstream press largely ignored it. Gizmodo reached a spokesperson for the FDA by phone to ask how many of the 13 million tests were sold in the U.S., but didn’t get an answer. A call to the agency on Wednesday was not returned. This is not necessarily a sign of negligence—FDA recall notices are posted routinely, and the volume is enormous. But it does highlight a systemic problem: important health information often gets buried in bureaucratic databases, and unless a journalist happens to stumble upon it, the public may never know. For the patients who take these tests, the lack of awareness is a disservice. For the healthcare providers who use them, the lack of clear, timely communication is a hazard. And for everyone else, it’s a reminder that the medical system is not a monolith. It’s made up of devices, regulations, corporate decisions, and human beings, all of which can fail in quiet ways.
So what should you do if you’re concerned? First, it’s important to understand that these tests were not sold directly to consumers. You likely didn’t take one at home. But if you had a pregnancy test in a hospital or clinic recently, and especially if you received a positive result that was later questioned or contradicted by an ultrasound or blood test, it’s reasonable to ask your provider whether the test they used was part of this recall. You have every right to know what happened and what it means. For healthcare professionals, the takeaway is clear: read the updated guidance, pay attention to unexpected results, and remember that no single test is perfect. A positive pregnancy test should always be interpreted in context, with follow-up testing when anything seems off. And for the rest of us, this recall is a reminder to stay curious and advocate for ourselves. Medical news can be overwhelming, and recalls like this one don’t always make the front page. But they matter. A false positive on a pregnancy test is not just a lab error. It’s a moment of joy, shock, fear, or confusion—sometimes all at once. It can change the course of a doctor’s visit, a treatment plan, or a life. The fact that more than 13 million of these tests were distributed around the world means that somewhere, right now, a patient might be receiving a result that isn’t true. The best we can do is shine a light on these quiet failures, ask hard questions, and remember that behind every test result is a person waiting to hear something that will shape their next steps. This recall, hidden in plain sight on a government website, is a story about all of that. It’s a story about the gap between what we know and what we’re told, and about the need for honesty, transparency, and compassion in every corner of healthcare.