LumiraDx recalls
3 official recalls and safety alerts involving LumiraDx since 2022-07, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with LumiraDx or the relevant agency.
- 2023-06-21
USLumiraDx recalls SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
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…
- 2022-11-02
- US
LumiraDx recalls LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are…
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,…
- 2022-07-27
- US
LumiraDx recalls LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
FDA · DeviceLumiraDxDomestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.Official notice →