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 |
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