Recall Z-1312-2021 ยท QKP Coronavirus Antigen Detection Test System.
LumiraDx
Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset.
| Date | Feb 3, 2021 |
| Status | Terminated |
| Reason | Two lots of test strips failed QC testing using blank buffer due to false positives. |
| Root cause | Process design |
| Action | On 2/23/2020, LumiraDx issued an Urgent Device Medical Corrective Field Action notice to customers, advising them of a mandatory field corrective action in the form of a software update for the LumiraDx SARS-CoV-2 Antigen (Ag) Test. |
| Quantity | 2186 devices |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.