,
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 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
