Coronavirus antigen detection test system - Product recall
Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2…
Why was Coronavirus antigen detection test system - Product recalled?
Two lots of test strips failed QC testing using blank buffer due to false positives.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
catalog #: L001000330001
- Product
- Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2…
- Recalling firm
- LumiraDx
- Quantity
- 2186 devices
- Distribution
- US nationwide distribution.
- Recall date
- April 7, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)