58,000 Pregnancy Tests Have Been Recalled Due To False Positives — Here's What You Need To Know

Discovering you are pregnant is a moment that comes charged with a swirl of emotions. But before you go to find out, you'll want to make sure it's not from a batch of Clear & Simple pregnancy tests that were recalled after women reported getting false positive results. The recalled products appear to only be in the United Kingdom, but here's everything you need to know to be sure extra sure.

The affected tests are specifically from a lot of Clear & Simple’s digital pregnancy tests, which are manufactured by Guangzhou Wondfo Biotech in China, according to a company press release. The recall is limited to the single test packages with a lot number of DM10220170710E and an expiration date of Jan. 9, 2020, according to Clear & Simple’s website.

The lot number and expiration date can be found on the bottom of the exterior of the box and is also printed on the tests plastic packaging, according to The Express. The twin pack digital pregnancy tests have not been affected, as noted by the press release.

"Of the estimated 58,000 of this Lot that have been distributed, it was found that very small numbers of the tests were producing inaccurate results," the company said in a press release. "Due to the small number of inaccuracies and our continued quality commitment to our customers the decision was taken to recall this lot from our retailers." The statement added, "Affected stocks have already been removed from retail shelves and are in our warehouse awaiting destruction."

Romper's request for further comment from Clear & Simple was not immediately returned.

As previously mentioned, the tests seem to have primarily been distributed in the United Kingdom, according to People, and the recall was announced by the country’s Medicines and Healthcare Products Regulatory Agency, as the BBC reported. The organization’s clinical director of Medical Devices said in a press release that anyone with questions about using home pregnancy tests should speak to their health care professional.

Guangzhou Wondfo Biotech, which manufactured the tests, provided a statement on the MHRA website stating that the false positives are the result of incorrect rib height on test strip brackets that “cause a large gap between the test strip bracket and the plastic enclosure of the Digital pregnancy." The statement added, "Therefore, it made a change in the light path of some products which eventually led to a larger signal value resulting in false positive results."

On its website, Clear & Simple sought to allay concerns, mentioning that all non-digital pregnancy tests are produced by another manufacturer and are not affected by the recall. The company also claims that its tests are 99 percent accurate.

Beyond this recall, The Bump, in general, urges women to stop and take a breath after receiving a positive result on a home pregnancy test. After all, as The Bump pointed out, there are roughly 40 weeks left to discover all that comes along with preparing for parenthood, so take things one trimester at a time. Parents also advised to follow up with a doctor to ensure that there hasn’t been an early miscarriage, which may have resulted in a positive result lingering on the home test.

While recalls can be a bit alarming, it's good to know that the company found the source of the problem and is taking steps to ensure the affected products are out of stores.