LumiraDx
LumiraDx appears in FDA public data with 6 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1970-2023, Class II) was initiated on April 25, 2023.
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1970-2023 | Class II | SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intend | April 25, 2023 |
| Z-0135-2023 | Class III | LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The L | September 23, 2022 |
| Z-1450-2022 | Class II | LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip | June 24, 2022 |
| Z-1451-2022 | Class II | LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control | June 24, 2022 |
| Z-1312-2021 | Class II | Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of | February 3, 2021 |
| Z-1132-2021 | Class II | LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syn | January 11, 2021 |