Class I - Dangerous
Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient may cause injury or medical intervention to remove part of the swab
LumiraDx
Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 Ag LQCs within batch 2002204017, which should have been assigned SARS-CoV-2 Ag lot numbers resulting in an error message and preventing use of the LQC
Class I - Dangerous
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
Class I - Dangerous
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
Two lots of test strips failed QC testing using blank buffer due to false positives.
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.