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Public Alert No.0041/2021 – Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue: FDA Safety Communication

October 25, 2021,

The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed by U.S Food and Drug Administration (FDA) about a safety communication of potential for false positive results with certain lots of the Ellume COVID-19 Home Test, due to a recently identified manufacturing problem. For these tests, a “false positive” is a test result that indicates that a person has the virus when they do not actually have it. Negative results do not appear to be detected because of the manufacturing problem.

The Ellume COVID-19 Home Test is an antigen test that detects proteins from the SARS-CoV-2 virus from a nasal sample in people 2 years of age and older. The Ellume COVID-19 Home Test is for people with or without COVID-19 symptoms.

The FDA is working closely with Ellume to assess the company’s additional manufacturing checks and other corrective steps to help ensure that the issue is resolved.

PRODUCT IMAGE

PRODUCTS DETAILS

Master Lot Number Final Kit Lot Number Expiration Date Retailer/Distributor
October 1, 2021 Notification
21047-4 21047-4 February 28, 2022 Department of Defense; Institution
21047-5 21047-5 February 28, 2022 Department of Defense
21089-1 21089-1 March 31, 2022 Department of Defense; Institution
21099-1 21099-1 (AUS) March 31, 2022 Retailer
21099-1 (USA) March 31, 2022 Retailer
21117-1 21117-1 April 30, 2022 Department of Defense
21124-1 21124-1 April 30, 2022 Retailer
21125-1 21125-1 April 30, 2022 Retailer
PF03X-H PF03W-H May 31, 2022 Retailer
PF03V-H May 31, 2022 Retailer
PF03S-H May 31, 2022 Retailer
PF03T-H May 31, 2022 Retailer
PF057-H PG07T-H May 31, 2022 Retailer
PG07Q-H May 31, 2022 Retailer
PG082-H May 31, 2022 Retailer
PG07R-H May 31, 2022 Retailer
PG07S-H May 31, 2022 Retailer
PF05W-H PF05M-H May 31, 2022 Retailer
PF05E-H May 31, 2022 Retailer
PF05Y-H May 31, 2022 Retailer
PF05H-H May 31, 2022 Retailer
PF05J-H May 31, 2022 Retailer
PF069-H PF06J-H May 31, 2022 Retailer
PF06D-H May 31, 2022 Retailer
PF06B-H May 31, 2022 Retailer
PF06C-H May 31, 2022 Retailer
PF06E-H PF06G-H April 30, 2022 Retailer
PF068-H April 30, 2022 Retailer
PF066-H April 30, 2022 Retailer
PF067-H April 30, 2022 Retailer
PF06N-H PF06P-H May 31, 2022 Retailer
PF06R-H May 31, 2022 Retailer
PF06Q-H May 31, 2022 Retailer
PF06Z-H PG07X-H June 30, 2022 Retailer
PF070-H June 30, 2022 Retailer
PG07Z-H June 30, 2022 Retailer
PF071-H June 30, 2022 Retailer
PG074-H June 30, 2022 Retailer
PG080-H PG084-H June 30, 2022 Retailer
PG081-H June 30, 2022 Retailer
PG08H-H PF065-H May 31, 2022 Retailer
PF060-H May 31, 2022 Retailer
PH08X-H PH08Y-H May 31, 2022 Retailer
October 11, 2021 Notification
PG083-H PG085-H June 30, 2022 Retailer
21119-1 21119-1 April 30, 2022 Retailer
PG07H-H PG07K-H June 30, 2022 Retailer
PG07J-H June 30, 2022 Retailer, Institution
PG076-H PG078-H June 30, 2022 Retailer
PG077-H June 30, 2022 Retailer
PH093-H PH09C-H June 30, 2022 Retailer
21049-8 21049-8 February 28, 2022 Department of Defense, Retailer
21113-1 21113-1 (Retail) April 30, 2022 Retailer
21192-346 21192-346 July 31, 2022 Department of Defense
21193-193 21193-193 June 30, 2022 Department of Defense
PF05V-H PF04Z-H May 31, 2022 Retailer, Institution
PF06K-H May 31, 2022 Retailer, Institution
PF058-H May 31, 2022 Retailer, Institution
PF072-H PG075-H May 31, 2022 Retailer
PG073-H May 31, 2022 Retailer
PH097-H PH098-H June 30, 2022 Retailer
PH09A-H PH099-H May 31, 2022 Retailer
21192-998 21192-998 June 30, 2022 Department of Defense
PF052-H PF049-H May 31, 2022 Retailer
PF04A-H May 31, 2022 Retailer
PF04B-H May 31, 2022 Retailer
PF04C-H May 31, 2022 Retailer
PF04D-H May 31, 2022 Retailer
PF04E-H May 31, 2022 Retailer
PF04F-H May 31, 2022 Retailer
PF04G-H May 31, 2022 Retailer
PF04H-H May 31, 2022 Retailer
PF04J-H May 31, 2022 Retailer
PF04K-H May 31, 2022 Retailer
PF04M-H May 31, 2022 Retailer
PF04Q-H May 31, 2022 Retailer
PF04W-H May 31, 2022 Retailer
PF04X-H May 31, 2022 Retailer
PF04Y-H May 31, 2022 Retailer
PF064-H May 31, 2022 Retailer
PF056-H PF03Y-H April 30, 2022 Retailer
PF03Z-H April 30, 2022 Retailer
PF044-H April 30, 2022 Retailer
PF04P-H April 30, 2022 Retailer
PF05G-H PF041-H May 31, 2022 Retailer
PF042-H May 31, 2022 Retailer
PF043-H May 31, 2022 Retailer
PF045-H May 31, 2022 Retailer
PF046-H May 31, 2022 Retailer
PF047-H May 31, 2022 Retailer
PF04N-H May 31, 2022 Retailer
PI0AK-H PE01T-H April 30, 2022 Department of Defense, Retailer
PE01V-H April 30, 2022 Department of Defense, Distributor, Retailer
PE01W-H April 30, 2022 Department of Defense, Distributor, Retailer
PE01X-H April 30, 2022 Department of Defense, Distributor, Retailer
PE021-H April 30, 2022 Department of Defense, Retailer
PH0A3-H PH0A4-H July 31, 2022 Retailer
PH09F-H PH09G-H July 31, 2022 Retailer
21152-1 21152-1 May 31, 2022 Department of Defense
PE02Q-H PE02M-H April 30, 2022 Retailer
PE02N-H April 30, 2022 Retailer
PE02P-H April 30, 2022 Retailer

RECOMMENDATIONS

NAFDAC implores importers, distributors, and consumers in possession of the recalled lots of  Ellume COVID-19 Home Test to discontinue sale or use and handover remaining stock to the nearest NAFDAC office.

Health professionals and patients are encouraged to report adverse events or quality problems experienced with the use of these medicines to the nearest NAFDAC office, NAFDAC PRASCOR [20543 or 0800-1-NAFDAC (0800-1-623322) TOLL FREE from all networks] or via pharmacovigilance@nafdac.gov.ng or via eReporting platform available on the NAFDAC website www.nafdac.gov.ng or via Med Safety Application available for download on Android and IOS stores.

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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