COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

COVID-19 Briefings

Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

FDA Issues Warning Letter to KBMO Diagnostics for Advertising Unauthorized At-Home SARS-CoV-2 Testing

warning unauthorized Covid tests

Unauthorized at-home SARS-CoV-2 testing draws another warning letter from FDA.

The US Food and Drug Administration (FDA) issued a warning letter June 17, 2020, to KBMO Diagnostics, LLC, for “adulterated and misbranded products related to COVID-19.” The FDA made this notification public on June 23, 2020. 

The warning letter quoted KBMO’s websites as saying “The Blood Spot (fingerstick) test has been released. Doctors can order the test and we will send a fingerstick test to the home of the patient who will UPS the dry blood spot card to the KBMO laboratory.”

This marks the second time that the FDA has sent warning letters to companies for adulterated and misbranded COVID-19 testing. On June 10, 2020, the FDA sent warning letters to three companies that offered at-home SARS-CoV-2 testing using methods that had not been authorized by the FDA. (See “FDA Sends Warning Letters to Companies Improperly Marketing At-Home SARS-CoV-2 Antibody Tests.”)

KBMO Diagnostics CEO James White responded to a media inquiry that the warning letter “was more about a number of our clients who took it upon themselves to advertise at-home sample collection and testing, which is not what we have been doing.” White said, “Venipuncture samples are collected and sent to our laboratory for processing under CLIA high-complexity guidelines.”

KBMO’s website no longer states the claims cited in the FDA warning letter, instead only offers venipuncture samples that are processed at their CLIA-certified laboratory in Massachusetts.

Related Resources:

FDA Sends First COVID-19 Testing Warning Letters

KBMO Diagnostics Warning Letter

KBMO Dx Receives FDA Warning About Unauthorized At-Home Collection for Coronavirus Testing