8-4-2024 (SINGAPORE) The Ministry of Health (MOH) announced on Monday that approximately 5,300 cord blood units stored in a second Cordlife tank and a dry shipper have been classified as “non-viable.” This comes in addition to the roughly 2,200 cord blood units previously damaged in the first tank, impacting at least 2,150 clients.
Cordlife, a cord blood banking company, has been under intense scrutiny since November last year when it was revealed that seven of its 22 storage tanks had been exposed to temperatures above the acceptable limit for cord blood units.
Following further testing directed by MOH, it was determined that cryopreserved cord blood units stored in one of the storage tanks (Tank B) and the dry shipper are at high risk of adverse impact due to temperature fluctuations, rendering approximately 5,300 cord blood units non-viable for stem cell transplant purposes. This development affects 5,300 active clients, according to Cordlife Singapore.
While the remaining five tanks were assessed to be at low risk, MOH recommended further testing of a larger number of cord blood units in these tanks to obtain more statistically significant results.
The testing process involved sample testing through a third-party laboratory. Out of the samples tested from Tank B and the dry shipper, a significant number failed, indicating the impact of temperature fluctuations. Root cause analysis revealed issues such as insufficient liquid nitrogen in Tank B and inadequate monitoring of the dry shipper.
As a response, MOH instructed Cordlife to inform affected clients and offer refunds of annual fees for clients with cord blood units stored in high-risk tanks, along with waiving future storage fees until their child turns 21. Cordlife also committed to finding suitable cord blood units if needed for transplant purposes.
The financial impact on Cordlife is estimated to be around S$9.2 million (US$6.8 million) due to refunds and waived fees, affecting the company’s financial results for the year ending Dec 31, 2024.
Further tests on the five low-risk tanks, storing approximately 14,000 cord blood units, yielded positive results, with all samples passing viability and potency tests. MOH recommended additional testing of a larger number of cord blood units in these tanks to ensure statistical significance, with Cordlife agreeing to conduct further tests over the next year.
MOH advised affected clients to await the test results before making any decisions regarding the transfer of cord blood units to another storage facility due to significant risks involved in such transfers. Additionally, MOH will continue to closely monitor Cordlife’s rectification efforts to address identified weaknesses.
