CORDLIFE GROUP LIMITED SERVED ONE-YEAR SUSPENSION NOTICE FOR CORD BLOOD BANKING SERVICES

The Ministry of Health (MOH) has issued a Notice of Intent to Cordlife Group Limited (Cordlife) on 29 September 2025 to suspend its cord blood banking services for a period of one year. Cordlife will have 14 days to submit its written representations. This suspension arises from adverse findings from MOH’s follow up audit of Cordlife’s operations conducted this year, after the calibrated resumption of operations in September 2024. With the suspension, Cordlife will be required to focus on properly maintaining the safety and quality of its existing cord blood units, and will not be able to bank new cord blood units.

2          In December 2023, following lapses in ensuring temperature control of some cord blood unit (CBU) storage tanks, MOH had directed Cordlife to stop the collection, testing, processing and/or storage of any new cord blood for a period of six months. This was extended by an additional three months on 15 June 2024 for Cordlife to complete the validation of its new cord blood processing method.

3          Two audits conducted by MOH in August and November 2024 showed that Cordlife had satisfactorily addressed critical shortcomings. Cordlife was then allowed to resume its cord blood banking operations in a calibrated manner from 15 September 2024. Its licence was subsequently renewed for one year from 14 January 2025, with a planned mid-point audit by MOH in July 2025 to ensure that Cordlife could sustain its compliance with regulatory requirements.

Findings from Mid-Point Audit

4          The mid-point audit in July 2025 found that Cordlife had sustained its improved temperature monitoring practices and had kept an accurate inventory of its cord blood units. However, Cordlife had failed to sustain compliance with regulatory requirements in other key operational areas, including governance, incident reporting and management, as well as processes involving collection, testing and processing of new CBUs collected since January 2025.

5          MOH also observed that the key personnel who had contributed to the improvements had resigned and there did not appear to be a properly established handover process. Cordlife's Clinical Governance Officer (CGO) was also found not to have provided proper oversight and guidance, which had led to the under-reporting of incidents and process failures across the collection, testing and processing of the new CBUs since January 2025.

6          The significant lapses in the collection and processing of new CBUs are as follows:

a)    Cordlife proceeded to store CBUs which did not reach the appropriate temperature for cryopreservation, and there was no evidence of appropriate investigation as to whether the deviations from the validated cryopreservation process would have caused damage.

b)    The CGO advised staff inappropriately that these were not issues of concern, which resulted in future similar incidents not being reported and investigated, and no appropriate corrective or preventive actions implemented.

c)    Cordlife continued to use cord blood collection bags which were exposed to temperature excursions without validating whether the collection bags should still be used and if the quality of the CBU may be affected.

7          These audit findings were thoroughly reviewed with a panel of experts. Taking into account the need to allow Cordlife time to look into its key operational areas, including governance, incident reporting and management and its workflow and processes from collection to processing, the decision was made to suspend Cordlife’s cord blood banking services for new CBUs (see Annex A for a detailed timeline of events).  

Update on Findings from Testing of Low-Risk Tanks

8          Following Cordlife’s previous suspension of collection and processing of new CBUs in December 2023, Cordlife was required to conduct sample testing of its CBUs to ascertain their viability and extent of damage of the temperature warming events.  The initial testing of 30 samples from across all five tanks had passed both viability and potency tests, and Cordlife had agreed to test over 200 additional samples to achieve more statistically significant results.

9          The review of the expanded testing results was completed on 26 September 2025. They showed that samples from two of the tanks met the criteria for viability and potency, but samples from the other three tanks did not. The testing protocol only allowed one sample to fail in each tank for the tank to meet the acceptance criteria. Specifically, the number of CBUs that failed the testing in the three tanks C, D and E were 2 of 65, 9 of 65, and 3 of 64 respectively (see Annex B for further information on the results). Cordlife’s root cause analysis could not identify conclusive reasons for what could have caused the tested samples in the three tanks to fail to meet the criteria. Hence, MOH has directed Cordlife to conduct a full investigation on the testing results.  

Strict Regulatory Actions to be Taken against Cordlife

 10        Cordlife’s lapses are a serious matter of concern.  MOH has therefore issued a Notice of Intent to suspend its cord blood banking licence for one year, to allow Cordlife to focus on addressing its lapses. Should the suspension be proceeded with, Cordlife will not be allowed to carry out any cord blood banking activities for new CBUs during the suspension period, except to maintain the safety and quality of existing stored CBUs and facilitate retrievals for transplant or to another cord blood bank. Cordlife will only be allowed to release stored CBUs for clinical use after a suitably qualified haematologist has assessed that it is fit for the intended clinical use.

 11        In addition, MOH has directed Cordlife to replace its current CGO, review all laboratory records of the approximately 160 CBUs collected since the resumption of its cord blood banking services in January 2025, and to identify and resolve any deviations from Cordlife’s established policies. Cordlife must also inform clients if their CBUs have been affected, and offer counselling by a haematologist on the implications on potential clinical uses of the CBU.

 Cordlife Urged to Engage Affected Clients

 12        The Ministry recognises that these findings may be distressing to many Cordlife clients, and they may now be contemplating withdrawal of their CBUs from Cordlife.

 13        MOH strongly urges Cordlife to proactively engage its clients and address their concerns, including on issues relating to their contracts with Cordlife. 

 14        MOH recognises that Cordlife’s clients may wish to transfer CBUs to alternate providers. MOH has initiated discussions with other cord blood banks in Singapore on their plans should they be approached to receive transfers of CBUs. Clients may contact the cord blood banks directly for further details. 

 15        However, transfer of CBUs, whether to local or overseas cord blood banks, carries risks and should be considered carefully. Alternative sources of stem cells, such as donated cord blood or transplant of bone marrow or peripheral blood stem cells, remain available for children who require transplants.

16        MOH will continue to closely supervise Cordlife’s rectification of the identified lapses. Should Cordlife continue to fail to meet regulatory requirements, MOH may have to assess and decide whether Cordlife’s licence to operate should be revoked.

Annex A: Timeline of Events

Annex B: Results from Low-Risk Tank Testing

 In November 2023, MOH directed Cordlife to conduct testing of six storage tanks (Tanks B, C, D, E, F, G) and a dry shipper which had been exposed to suboptimal storage temperatures. One storage tank (Tank A) had already been deemed to be at high risk of being adversely affected.

The results showed that CBUs stored in one of the storage tanks (Tank B) and the dry shipper were at high risk of adverse impact due to temperature warming events. The remaining five tanks (Tanks C, D, E, F, G) were assessed to be at low risk of being adversely affected by the temperature warming events. MOH experts recommended that Cordlife test a larger number of CBUs in these five tanks to obtain a more statistically significant result and further ascertain the status of the CBUs stored in these tanks.

Cordlife has completed further testing of these five tanks, with the results as follows. The testing protocol only allowed one sample to fail in each tank for the tank to meet the acceptance criteria. Three out of five tanks did not meet overall acceptance criteria.