CSL contaminated batches of Albumin recalled after lengthy delays to notify.
Yesterday the Therapeutic Goods Administration (TGA) in Australia quarantined CSL Human Albumin solutions from further use while an assessment is carried out into the safety of the products.
That followed notification from CSL Biotherapies that some batches of the solutions manufactured before January 25 had been contaminated with coolant ethylene glycol, due to equipment failure.
As a result the TGA issued a recall to all hospitals throughout Australia, New Zealand, Hong Kong and Singapore for the albumin, the main protein in plasma, manufactured before January 25.
CSL had advised the TGA that levels of contamination were "very low" and adverse clinical effects appeared unlikely. So far, CSL had not found evidence of anyone who received the albumin suffering ill effects. Toxicity due to ethylene glycol would occur acutely and delayed effects beyond 72 hours would not be expected.
CSL was continuing further tests ''to quantify the levels of contamination and the extent of the batches affected''.
Today a New Zealand Ministry of Health spokesman said CSL had not yet identified any batches of albumin in the country that were affected, but testing was continuing.
Hospitals had been advised and were working with the New Zealand Blood Service to manage use of the existing stock.
The ministry was also "promptly" sourcing stock it could be sure of.
In Australia, the TGA said that as a result of the action to quarantine stocks, supplies of albumin may be limited in the immediate future.
Stocks in Australia were being quarantined from further use until safety implications had been fully assessed.
Advice released by the TGA last night on the effect of ethylene glycol said ingestion of the coolant could lead to acute renal failure and trigger symptoms consistent with alcohol intoxication.
The highest risk would be anticipated among those patients requiring the largest volumes of albumin.
