LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA recall
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips…
Why was LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA recalled?
Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnecessary treatment or quarantine.
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 #:L016000109048 Lot #: 5000269 (GM2000238), 5000280 (GM2000232), 5000306 (GM2000261) (Updated 3/15/2021) 5000323 (GM2000354), 6000142 (GM2000296), 6000100 (GM2000322)
- Product
- LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips…
- Recalling firm
- LumiraDx
- Quantity
- 3,274,272 strips (Updated 3/15/2021 added 69,168 strips)
- Distribution
- Worldwide distribution. US states of CA, GA, PA, SD. (Updated 3/15/2021) Austria, Germany, Ireland, Italy, Lebanon, Netherlands, Slovenia, Spain, United Kingdom.
- Recall date
- February 24, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)