No lives were put at risk by the HIV testing kits recalled last week, Health Minister Dr Aaron Motsoaledi and representatives of the World Health Organisation (WHO) said in Joburg on Monday.
Last week, 500 000 SD-Bioline HIV testing kits were recalled by the Department of Health after it was reported that the kits had been delisted for purchase by the WHO.
The recall was a precaution that should not deter South Africans from undergoing HIV tests, experts and government officials said.
In November, the WHO did a laboratory assessment of two batches of the kits and found that 50 percent of them gave invalid readings. As a result, they delisted them from procurement.
Motsoaledi said the kits had been tested and found to be working by the National Institute of Communicable Diseases (NICD) and this was the information that was acted on when securing the tender.
“It was found that the two institutions (the WHO and NICD) were dealing with different batches from the same company, meaning that the company is sending different kits to different countries.”
However, he added that next month the WHO would review the NICD’s quality-control mechanisms and procedures to check that they were up to standard.
Motsoaledi pointed a finger at “junior officials” who approved the process and who, he emphasised, should have alerted him or another power to the discrepancy. He said removing the kits was an act of caution.
What will be done with the 7 million kits the government has tendered, will be decided after an investigation into the process had been done by the director-generals of treasury and health.
Motsoaledi said the portion of the tender for HIV-testing kits given to the Standard Diagnostics company represented only 30 percent of the total tender, and thus there would not be a shortage of kits pending a decision.
Kees De Joncheere, of the WHO, said that recalls happened, even when systems were strict and involved high-quality companies, and that government action to minimise the damage and prevent a recurrence was extremely important… Nobody’s life has been put at risk.” - The Star