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.
This recall has been terminated (originally issued February 3, 2021).
- Company
- Lumiradx
- Recall Initiated
- February 3, 2021
- Terminated
- July 13, 2022
- Recall Number
- Z-1312-2021
- Quantity
- 2186 devices
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Two lots of test strips failed QC testing using blank buffer due to false positives.
Distribution
US nationwide distribution.
Lot / Code Info
catalog #: L001000330001
Root Cause
Process design
Action Taken
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.
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