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58,000 Pregnancy Tests Recalled After False Positives Reported

Photograph by Twenty20

Digital pregnancy tests are often touted for their accuracy and being easy to understand, but before you use one, you may want to check to see if your test is affected by a major recall. After some women have been wrongly told they were expecting, more than 58,000 Clear & Simple at-home digital pregnancy tests have been recalled by the manufacturer, Guangzhou Wondfo Biotech.

Clear & Simple have reassured consumers on its website that "very small numbers of the tests" from one batch were producing inaccurate results and all other Clear & Simple tests remain more than 99 percent accurate.

"Affected stocks have already been removed from retail shelves and are in our warehouse awaiting destruction," the statement reads. "We are very sorry for any inconvenience and upset that this manufacturing fault may have caused, and we are working closely with the manufacturer to ensure the accuracy of future supplies."

Photograph by Clear & Simple
Photograph by Clear & Simple
False positives tend to be much rarer than false negatives.

Here's what to check for:

- The batch seems to have been primarily distributed in the United Kingdom.

- The affected lot number is DM10220170710E with an expiration date of Jan. 9, 2020. Look for the lot number at the end of the box or printed on the satchet. Only this lot number is affected.

- The recall does not apply to other batches of the product or the twin-pack digital stock.

If you've purchased an affected test, return the product to your pharmacy or shop and seek alternative testing methods.

False positives tend to be much rarer than false negatives. So, how could this have happened? According to an alert by the manufacturer, the false positives may be because of "a large gap between the test strip bracket and the plastic enclosure of the Digital pregnancy," which "made a change in the light path ... which eventually led to a larger signal value."

Finding out pregnancy results can be a life-changing moment and bring with it a whirlwind of emotions. But no matter what at-home test you use, if you get a positive result, it's a good idea to confirm it with a medical professional.

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