CSL Biotherapies is under fire from health authorities for taking six weeks to alert regulators that anti-freeze had leaked into a tank used for the human blood product albumin.
BLOOD products company CSL Biotherapies is under fire from health authorities for taking six weeks to alert regulators that anti-freeze had leaked into a tank used for the human blood product albumin.
The company's disclosure to authorities this week triggered a nationwide recall from hospitals of all stocks of albumin, a plasma protein administered to serious burns and trauma patients.
CSL discovered small amounts of the ethylene glycol in an albumin tank on January 25. The chemical, used to control temperature, had leaked through a hairline crack in the casing around the tank.
Initial tests found no contamination and it was only on Wednesday this week after more testing that the company alerted the Therapeutic Goods Administration that it had identified contaminated albumin.
A spokeswoman for CSL said the later testing ''unexpectedly'' found batches produced before an inspection on December 14, showed presence of contaminant, albeit at low levels. The company said it made a ''quick and thorough response''.
But Australia's chief medical officer, Dr Chris Baggoley, told The Saturday Age yesterday that the Therapeutic Goods Administration would be pressing CSL for answers as to why it took until this week for the company to inform it. ''That is a question the TGA will be putting to CSL, as to why, when they found the problem related to manufacturing in late January, even if they thought they had it contained, why did they not advise the TGA at the time.''
Dr Baggoley said the company only alerted the TGA this week after further checking of samples from last year revealed traces of the ethylene glycol.
Because CSL was still trying to find out when the contamination started ''we have to assume that all albumin in hospitals could potentially be contaminated'', Dr Baggoley said.
Public hospital spokeswoman Prue Power has called for a full inquiry.