10/5/2021- 9:01 p.m.
Nearly 200,000 Covid-19 testing kits RECALLED, due to “manufacturing issue” that delivered FALSE positives
The FDA issued a notice Tuesday alerting the public of “the potential for false positive results” with certain lots of Australian company Ellume’s Covid-19 Home Test, a rapid antigen kit used to detect Coronavirus using nasal swabs and a smartphone app.
While neither the FDA nor Ellume gave the exact amount of kits that are being recalled, the New York Times said the number was “nearly 200,000,” with the company so far supplying 3.5 MILLION tests in total to the US.
“Negative results do not appear to be affected by the manufacturing issue,” the FDA said, adding it is “working closely” with Ellume to assess “corrective steps” going forward.
