Recall Z-1312-2021— LumiraDx
Class II · Terminated
Class II FDA medical device recall by LumiraDx, initiated 2021-02-03, terminated 2022-07-13. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Two lots of test strips failed QC testing using blank buffer due to false positives..
- Recalling firm
- LumiraDx
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-02-03
- Terminated
- 2022-07-13
- Firm location
- Waltham, MA, United States
Product 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.
Reason for recall
Two lots of test strips failed QC testing using blank buffer due to false positives.
Data sourced from openFDA. This site is unofficial and independent of the FDA.