LumiraDx Recall 87366
Description: 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.
LumiraDx Recall 87366 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1312-2021 |
| Event ID | 87366 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US nationwide distribution. |
| Quantity | 2186 devices |
| Recall Reason | Two lots of test strips failed QC testing using blank buffer due to false positives. |
| Device Classification | 20210407 |
| Device Code Info | catalog #: L001000330001 |
| Center Classification Date | 20210326 |
| Recall Initiation Date | 20210203 |
| Recalling Firm | LumiraDx |
| Initial Notification | Letter |
| Similar To |