Recall Z-0183-2022— ELLUME LTD

Name: FDA recall Z-0183-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-01

Class I · Ongoing

Class I FDA medical device recall by ELLUME LTD, initiated 2021-10-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Ellume COVID-19 Home Test. Reason: Due to a higher rate of false positive test results..

Recalling firm: ELLUME LTD
Classification: Class I
Status: Ongoing
Initiated: 2021-10-01
Firm location: East Brisbane, N/A, Australia

Product description

Ellume COVID-19 Home Test

Reason for recall

Due to a higher rate of false positive test results.

Data sourced from openFDA. This site is unofficial and independent of the FDA.