The National Agency for Food and Drug Administration and Control (NAFDAC) is alerting the public that the Singapore’s Health Sciences Authority (HSA), on June 6, drew the attention of individuals to the recall of a brand of test kit, SD Bioline HIV Ag/Ab combo kits.
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.
According to the HSA, 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.”
The details of the products are as follows:
BRAND NAME: SD Bioline HIV Ag/Ab combo kits.
MANUFACTURER: Standard diagnostic Inc. South Korea
LOT NUMBER: All lots from February, 2016 up to May, 2017
Healthcare Provider’s Action.
- Healthcare providers in possession of these affected products should stop using them and submit them to the nearest NAFDAC office.
- Healthcare providers and patients are 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 firstname.lastname@example.org