LumiraDx Recalls
6 recalls on record · February 24, 2021 to June 21, 2023 · Medical Devices
Recalls by year
21
22
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 21, 2023Medical DevicesFDA
LumiraDx recalls SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Cata
Hazard: 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
November 2, 2022Medical DevicesFDA
LumiraDx recalls LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Q
Hazard: 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
July 27, 2022Medical DevicesFDA
LumiraDx recalls LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Hazard: Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
July 27, 2022Medical DevicesFDA
LumiraDx recalls LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
Hazard: Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
April 7, 2021Medical DevicesFDA
LumiraDx recalls Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid pr
Hazard: Two lots of test strips failed QC testing using blank buffer due to false positives.
February 24, 2021Medical DevicesFDA
LumiraDx recalls LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 A
Hazard: 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.