FDA Enforcement
Class II
Terminated
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.
Recall: Z-1312-2021
·
Reported April 7, 2021
Enforcement
- Recall Number
- Z-1312-2021
- Event ID
- 87366
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- LumiraDx
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 7, 2021
- Initiation Date
- February 3, 2021
- Classification Date
- March 26, 2021
- Termination Date
- July 13, 2022
- Address
- 221 Crescent St, Waltham, MA, 02453-3475, United States
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
Two lots of test strips failed QC testing using blank buffer due to false positives.
Code Info
catalog #: L001000330001
Distribution
US nationwide distribution.
Quantity
2186 devices