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LumiraDx FDA Recalls

6 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. CataClass IIApr 25, 2023Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Tes	Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If t	Class IIDevices	Apr 25, 2023
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 QClass IIISep 23, 2022Assigned vial lot numbers for the incorrect type of product.	Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly	Class IIIDevices	Sep 23, 2022
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality ControlClass IIJun 24, 2022Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test t	Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA	Class IIDevices	Jun 24, 2022
LumiraDx SARS-CoV-2 Antibody (Ab) Test StripClass IIJun 24, 2022Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test t	Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA	Class IIDevices	Jun 24, 2022
Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid prClass IIFeb 3, 2021Two lots of test strips failed QC testing using blank buffer	Two lots of test strips failed QC testing using blank buffer due to false positives.	Class IIDevices	Feb 3, 2021
LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 AClass IIJan 11, 2021Observations of potential false positive results in the spec	Observations of potential false positive results in the specified lots. Use of these test strips may result in	Class IIDevices	Jan 11, 2021

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