FDA Recall
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
·
Initiated February 3, 2021
Recall
- Recall Number
- Z-1312-2021
- Event Number
- 87366
- Firm
- LumiraDx
- FEI Number
- 3012642695
- Product Code
- QKP
- Status
- Terminated
- Root Cause
- Process design
- Initiated
- February 3, 2021
- Terminated
- July 13, 2022
- Address
- 221 Crescent St, Waltham, MA, 02453-3475
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.
Action
On 2/23/2020, LumiraDx issued an Urgent Device Medical Corrective Field Action notice to customers, advising them of a mandatory field corrective action in the form of a software update for the LumiraDx SARS-CoV-2 Antigen (Ag) Test.
Distribution
US nationwide distribution.
Quantity
2186 devices