An Australian company has recalled nearly 200,000 COVID-19 testing kits out of 3.5 million supplied to the US.

Ellume has had to recall these kits approved by the Food and Drug Administration (FDA) as these kits had an unspecified manufacturing issue that was resulting in false Covid positives.

The company has warned its users that some of its kits may have “the potential for false positive results”.

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“Negative results do not appear to be affected by the manufacturing issue,” the FDA said, adding that it is working with the Australian company to bring in ‘corrective steps’ quickly.

Meanwhile, users have been advised to consult healthcare providers and experts if they have received a positive result through the kits. Users have also been instructed to carefully check the list provided by Ellume that states its problematic lots that had been dispatched between April and August.

All users who have received faulty kits will be given a replacement as soon as they submit receoits.

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“The increase in false positives was the result of a supply chain issue with one of the test components. Because of the proprietary information involved in the manufacturing process, we cannot offer more specifics,” an Ellume spokesperson said in a statement.

Till now, nearly 427,000 kits had been sent to the US out of which 42,000 results had been positive. Although it is still not clear that how many of these positives were false and which ones were correct.

However, the company has still not reported what exactly had caused this error and has cited trade secrets as a reason of the secrecy.