MFDS Recalls Yellow-Discolored 'Specimen Transport Media'

Recall of Some Asan Pharmaceutical Products Due to Quality Defects

Specimen Transport Medium

[Asia Economy Reporter Han Jinju] The Ministry of Food and Drug Safety has issued a recall for defective transport media that turn yellow when used to transport specimens collected for COVID-19 diagnostic testing.

On the 20th, the Ministry announced that Asan Pharmaceutical Co., Ltd., a medical device manufacturer located in Hwaseong-si, Gyeonggi-do, voluntarily recalled some batches of their "specimen transport media" due to discoloration quality defects. The recalled quantity is 26,850 units (batch number D1008, manufacturing date April 1, 2020).

This product is a medium used by medical institutions to transport or store specimens collected from patients for COVID-19 virus diagnostic testing to testing facilities. The medium consists of proteins, antibiotics, pH indicators, and other components.

Originally, the product appears as a pink liquid, but it turns yellow when contaminated. The Ministry suspects that the discoloration occurred due to contamination of the dispensing container and nozzle during the final stage of the manufacturing process when the medium is aliquoted in small amounts.

The product instructions include a caution stating "Do not use discolored products," and since discoloration is easily visible to the naked eye, the Ministry explained that it is unlikely that medical professionals at healthcare institutions would use defective products.

The Ministry urged, "Not only the discolored products but all products produced under the same batch number should be promptly recalled. Medical institutions that purchased these products should stop using them and actively cooperate with the manufacturer's recall. Even when using other specimen transport media, if discolored products are found, please do not use them."

This content was produced with the assistance of AI translation services.