By CBSLA Staff

VALENCIA (CBSLA) — More than 2 million Ellume COVID-19 Home Tests are under recall Friday due to the potential for a false positive result from a recently identified manufacturing issue, according to the FDA.

(credit: FDA)

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The recalled tests were manufactured by Ellume, an Australian firm with a facility in Valencia, between Feb. 24 and Aug. 11 and distributed between April 13 and Aug. 26. The initial recall of these COVID home tests was announced on Oct. 1, but was expanded this week to include 2,212,335 tests.

There have been 35 reports of false positive test results sent to the FDA, but no reports of death.

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The FDA issued an emergency use authorization on Dec. 15, 2020 to allow use of the home tests, which are available without prescription.

The tests are being recalled because they have higher-than-acceptable false positive test results for SARS-CoV-2, according to the FDA. A false positive test result with the Ellume tests could indicate a person has the virus when they do not actually have it, and the FDA is concerned that people could seek out unnecessary COVID treatments, delay treatment for another life-threatening illness that is not COVID, or possibly spread the virus if presumed positive people are grouped into a cohort based on false test results.

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Test users will be notified by Ellume if they used an affected test and received a positive result, but they can also find a product lot number on the sticker on the side of an Ellume test carton to check if it is part of the recall. Affected tests that haven’t been used yet will be disabled via a software update, according to the FDA.