Device product
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.
Z-1312-2021
Product summary
- Firm
- LumiraDx
- Event
- Event 87366
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2186 devices
- Official record key
device-enforcement:Z-1312-2021
Official wording
Reason: Two lots of test strips failed QC testing using blank buffer due to false positives.
Code information: catalog #: L001000330001
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Unknown
Two lots of test strips failed QC testing using blank buffer due to false positives.