US Maryland State Responds to Reports of Defective Korean Diagnostic Kits with "Upgrade According to FDA Standards" (Comprehensive)

Governor Hogan of Maryland and his spouse who purchased a Korean test kit [Photo by AP]

[Asia Economy Reporter Kim Yuri] The state of Maryland in the United States purchased Korean-made COVID-19 diagnostic kits but replaced them after about a month due to product defects, the Washington Post (WP) reported on the 20th (local time). However, Maryland stated that the replacement was not due to product defects, but rather an upgrade of the diagnostic kits according to conditions later set by the U.S. Food and Drug Administration (FDA).

WP reported that Maryland purchased 500,000 tests of the COVID-19 diagnostic kit 'LabGun' made by Korean company LabGenomics in two shipments starting April 18, at a total cost of $9.46 million including shipping. At that time, the U.S. was experiencing a shortage of diagnostic kits, so Governor Larry Hogan, known as the 'Korean son-in-law,' publicized the purchase extensively.

Maryland outsourced test processing to two laboratories, ICMD and CIAN, and WP reported that ICMD found issues with the kits. The Maryland state government then spent an additional $2.5 million to receive a new batch of 500,000 LabGun tests starting May 21 that complied with FDA-approved standards.

WP criticized the state government for not disclosing the replacement of the diagnostic kits, for not responding adequately to inquiries from state legislators, and noted that Governor Hogan responded by saying the kits were upgraded rather than fixed for defects. LabGun kits have been used in testing sites since around June 10, with 375,000 tests (75%) reportedly used so far.

However, Maryland explained that when the initial LabGun kits were imported in April, diagnostic kits were in very short supply in the U.S., and the FDA was still allowing some discretion to state governments rather than providing clear standards for diagnostic kits. Although they had secured the LabGenomics supply with difficulty, the FDA’s final approval criteria for LabGun kits on April 30 revealed that the initially supplied kits had issues with long testing times, leading Maryland to return the original kits and obtain new kits that met FDA standards. They emphasized that this was not due to product defects.