Recall Z-1132-2021 ยท QKP Coronavirus Antigen Detection Test System.
LumiraDx
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument and a LumiraDx Test Strip for the required test.
| Date | Feb 17, 2021 (initiated Jan 11, 2021) |
| Status | Terminated |
| Reason | Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnecessary treatment or quarantine. |
| Root cause | Nonconforming Material/Component |
| Action | On 01/28/2021, Lumiradx issued Urgent Medical Device Recall notices to customers via letter notifying customers the potential of false positive results in specified lots of LumiraDx SARS-CoV-2 Antigen (Ag) Test Strip. A false positive test result of a patient could result in potential exposure to unnecessary treatment or quarantine. (Updated 3/15/2021) On 2/26/2021, Lumiradx issued a second Urgent Medical Device Recall notice to customers via letter expanding the recall to include 3 additional lots. These lots are subject to recent feedback from a small number of customers regarding a small t |
| Quantity | 3,274,272 strips (Updated 3/15/2021 added 69,168 strips) |
| Distribution | Worldwide distribution. US states of CA, GA, PA, SD. (Updated 3/15/2021) Austria, Germany, Ireland, Italy, Lebanon, Netherlands, Slovenia, Spain, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.