Pregnancy Tests Recalled Globally Over False Positives

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. Gizmodo asked several times over the past week how many of the 13 million recalled tests were distributed in the U.S. but didn’t receive a response. The tests were also distributed in the United Kingdom, Canada, Italy, Ireland, Spain, Portugal, New Zealand, Hong Kong, Australia, Papua New Guinea, Fiji, Guam, and Sweden, according to the FDA notice. A spokesperson for Health Canada confirmed to Gizmodo that the pregnancy tests had been recalled in that country by a company called Innovacon, Inc., also based in San Diego, writing, “There were approximately 2,800 affected units sold to healthcare facilities in Canada. The device is intended for professional use only; healthcare professionals may continue to use the device, but should consider low hCG levels when interpreting results.” The recalled tests were sold under a number of different names, according to the FDA, including: Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527 McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Part:FHC-101/5000 Henry Schein One Step+ hCG Urine Strip Test, Model/ Part: FHC-101/9004072 Alere hCG Dipstick (25mIU/mL) in Urine, Model/ Part: FHC-101/92211 Cardinal Health hCG Dipstick Rapid Test CLIA Waived, Model/ Part: FHC-101/B-1077-21 Medline hCG Pregnancy Test Strip, Model/ Part: FHC-101/MPH11025HCG Pro Advantage by NDC Urine Pregnancy Test Strip, Model/ Part: FHC-101/P080023 Recall notices posted to the FDA’s website can sometimes be overlooked by mainstream press, given the enormous volume. The recall notice says that the recall was initiated on Aug. 20 and the notice wasn’t posted until Sept. 25. Gizmodo reached a spokesperson for the FDA over the phone this past Friday to see if they could provide any clarity on how many of the 13 million tests were sold in the U.S., but we didn’t receive an answer, and a call to the agency on Wednesday was not returned.