The lives of millions of South Africans could be at risk, and South Africa's health department has recalled 20 million government condoms as it scrambles to do damage control after allegations of corruption in the country's quality-assurance and standards body.

The condoms were recalled on 23 August after media reports alleged that Sphiwe Fikizolo, a testing manager at the South African Bureau of Standards (SABS), which is responsible for assuring that all condoms produced in the country conform to World Health Organisation standards, had accepted money from the manufacturer in return for certifying defective condoms.

Jeffery Hurwitz, executive director of Latex Surgical Products (Pty) Limited (LSP), which manufactured the condoms, Sajeev Joseph, an employee, and Fikizolo have been charged with fraud and corruption.

Despite the recall, health department spokesperson Sibani Mngadi maintained that only Choice condoms bearing the serial number 4308/ZLX had been affected, and 90 percent of government condoms were of good quality: of the 20 million LSP condoms recalled, only an estimated seven million would have been directly compromised by the alleged corruption.

Mngadi said the department distributed 400 million condoms annually, sourced from seven suppliers, including LSP, which supplied nine percent of the total.

SABS spokesman Erno Botes said the bureau had begun a full audit of all condom manufacturers in the country in response to the allegations, and had also reviewed all available test records for LSP condoms for the past year.

"When the case broke, we revisited the files; we still have records of the performance of batches," Botes said. "Under normal circumstances, these condoms would not have passed."

The audit included the test results for 91 batches, but Mike McNerney, the SABS general manager of food and health, admitted that the bureau had been unable to locate the results for 14 batches and said this was highly unusual.

He said it was important to understand what was meant by a failed batch. "If a batch fails, that means the risk of failure increases, but not that all condoms [in the batch] will fail. But the bottom line is that the products failed and never should have been released."

McNerney said laboratory tests, which often placed condoms under stresses above and beyond those of normal usage circumstances, might produce a worst-case scenario picture of the problem.

"We can't specifically quantify the increase in risk in terms of human use, we can only go off laboratory tests," he commented.

As of 28 August, the government had quarantined 4.5 million Choice condoms while it continued its public awareness campaign, the main intervention in the wake of the recall.

"We are trying to minimise the possibility of risk, which means we are trying to get through to as many people as possible about the recall," Mngadi said. "We are encouraging people who may really be uncertain about what this means for them to contact the AIDS helpline."

The recall is a blow to what has been a hard-fought condomisation campaign in the country. "It's definitely a setback. We've done a lot of work promoting this brand. The rebranding of the grey government condoms with the AIDS ribbon into Choice condoms meant an increase in annual distribution."

Mngadi said the recall had left communities suspicious of the government's free condoms. "We are working to find the best strategy to manage the damage done to the brand's reputation and the public's confidence in the product."

David Nowitz, senior marketing manager of the Society for Family Health (SFH), which has partnered the government for several years in branding and distributing the Choice condoms, said, "I think those behind the scandal have done the AIDS prevention cause a huge disservice. However, it's important for people to remember that we're talking about the actions of a couple of individuals, and not a whole public healthcare system."

At the Centre for AIDS Development, Research and Evaluation (CADRE), director Dr Warren Parker suggested that this series of events might provide an opportunity to rethink prevention.

"It's unfortunate that the selfish economic interests of people who put the programme in place ... have put the public at risk," he said. "The recall undermines what has been an overall very successful condom campaign with very strong logistics and increased in demand over time."

Parker praised the department's courage in dealing openly with the problem and added the recall might be food for thought. "It stresses the importance of multi-dimensional prevention programmes: for example, there is still a need to reduce concurrent and multi-partner sexual partnerships. In that sense, the recall may be an opportunity to refocus prevention efforts."