Cordlife expects to take a year for tests for the five tanks to be completed due to their complexity.SINGAPORE - An estimated additional 5,300 cord blood units from a tank and a dry shipper at Cordlife are unlikely to be suitable for stem cell transplant purposes and have been deemed non-viable, said the Ministry of Health in an update on April 8.
It was previously announced that around 2,200 CBUs in one of the affected tanks, called Tank A, were damaged and rendered unsuitable for stem cell transplants. It said six donated CBUs were selected from each tank for testing to ensure adequate coverage of temperature variations across the tank. If more than one CBU failed the first round of testing, another six donated samples were selected from the same tank for additional testing.
Based on the detailed analyses carried out, Tank B and the dry shipper recorded the highest temperature excursions of minus 11.6 deg C and minus 132.6 deg C, respectively, Cordlife said. The root cause analysis indicated that the temperature warming events in four out of five tanks were likely due to misplaced temperature probes during scheduled maintenance, or incorrect mapping of the temperature probe to the tank.
Cordlife said that during this process, it will pause any applicable billings for the five tanks until the results of the additional testing are released, with each tank being assessed individually. “MOH will continue to closely supervise Cordlife’s rectification of the weaknesses identified in their governance structure, processes, systems and documentation.”
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