Recall Z-0183-2022 ยท QKP Coronavirus Antigen Detection Test System.
ELLUME LTD
Ellume COVID-19 Home Test
| Date | Oct 1, 2021 |
| Status | Open, Classified |
| Reason | Due to a higher rate of false positive test results. |
| Root cause | Process control |
| Action | On 10/01/2021, the Recalling Firm communicated an "URGENT: MEDICAL DEVICE RECALL" Notification letter via email to its: -Distributors/retailer -Customers/users that include customers that have used the products within 2 weeks and beyond 2 weeks. The communications informed customer that the Recalling Firm has received a number of complaints stating false positive test results for it COVID-19 Home Test kits. If consumers have used an affected product before 09/17/2021 and tested positive are advised that their test results could have been incorrect. For Distributor and Retailers, they are ins |
| Quantity | 427,994 kits |
| Distribution | U.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.