The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed that the Singapore’s Health Sciences Authority (HSA), on 6th June, drew the attention of individual to the recall of a brand of test kit, SD Bioline HIV Ag/Ab combo kits.
People in Singapore who did a rapid HIV test between February 16 and May 17 have been advised to check with their clinics if they need to be re-screened, after a brand of test kit was recalled by the authorities.
Issuing a press statement, Health Sciences Authority (HSA) said, “HSA was notified by the local importer, Unison Collaborative, that nine lots of SD BIOLINE HIV Ag/Ab Combo assay were recalled by the product owner, Standard Diagnostics Inc. (SD).”
The HSA stated that it was notified by a Singaporean importer, Unison Collaborative, that nine (9) lots of the kits were recalled by the Korea based manufacturer, Standard Diagnostic Inc. due to their reduced sensitivity. According to the manufacturer, when a patient is in the early window period, the lower sensitivity of the affected lots may reduce detection with the possibility of a false negative result for this subset of patients.
The HSA informed that the SD Bioline HIV Ag/Ab Combo Assay test kit may be unable to detect the infection in the blood during the early stages of HIV infection.
Further information shows that five hundred and eighty four (584) of the SD Bioline HIV Ag/Ab combo kits were supplied to 27 healthcare facilities and 26 clinics and one general hospital in Singapore.
NAFDAC however advice the healthcare providers in possession of these affected products to stop using them and submit them to the nearest NAFDAC office.
Healthcare providers and patients are also encouraged to report adverse events associated with the use of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via email@example.com