MOH finds 5,300 more ‘non-viable’ cord blood units at Cordlife

One tank experienced a temperature excursion due to delayed replenishment of liquid nitrogen.

The Ministry of Health (MOH) has found an estimated 5,300 additional cord blood units (CBUs) that are deemed "non-viable" from a Cordlife Group tank and dry shipper.

Results from its recent investigation, the MOH termed the findings as "High-Risk Tanks," posing a higher risk of adverse effects from temperature excursions.

Since December 2023, the company has been sending CBUs from tanks under investigation to a third-party laboratory in Singapore for testing.

Six donated CBUs were selected from each tank for testing to ensure comprehensive coverage of temperature variations.

Results indicate that five cryogenic storage tanks, termed "Low-Risk Tanks," show low risk of adverse effects from temperature excursions. 

CBUs from these tanks exhibit cell viability and potency. The temperature excursions in four of the Low-Risk Tanks were attributed to maintenance issues and incorrect temperature probe mapping.

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The one tank experienced a temperature excursion due to delayed replenishment of liquid nitrogen.

Additional testing involving over 200 samples from the Low-Risk Tanks is planned for further assurance. Initial testing from these tanks was inconclusive, with subsequent tests showing varying levels of cell viability and potency.

The High-Risk Tanks experienced temperature excursions primarily due to deficiencies in temperature monitoring and liquid nitrogen replenishment procedures.

Cordlife plans to refund annual fees and waive subsequent fees for affected clients with CBUs stored in both the High-Risk Tanks and a previously identified tank deemed unsuitable for stem cell transplant purposes.

Financially, the refund and fee waivers for affected clients are estimated to result in a decrease in revenue and profit before tax.

Cordlife is collaborating with the MOH to prevent similar incidents in the future and is committed to implementing corrective measures by May.