Versea Diagnostics LLC FDA Recalls

4 recalls on file across devices, 0 of them Class I and 0 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
FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CClass IIJul 27, 2021Products may have been distributed to customers other than l	Products may have been distributed to customers other than laboratories certified under the Clinical Laborator	Class IIDevices	Jul 27, 2021
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgClass IIJul 27, 2021Products may have been distributed to customers other than l	Products may have been distributed to customers other than laboratories certified under the Clinical Laborator	Class IIDevices	Jul 27, 2021
Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, Class IIJul 27, 2021Products may have been distributed to customers other than l	Products may have been distributed to customers other than laboratories certified under the Clinical Laborator	Class IIDevices	Jul 27, 2021
CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nClass IIJul 27, 2021Products may have been distributed to customers other than l	Products may have been distributed to customers other than laboratories certified under the Clinical Laborator	Class IIDevices	Jul 27, 2021