Ministry cites failures in governance, reporting, and processing of new cord blood units

Singapore’s Ministry of Health (MOH) has issued a notice of intent to suspend Cordlife Group’s cord blood banking services for one year, following a July audit that uncovered serious lapses in governance and operations.

Suspension Notice Issued

On September 29, 2025, MOH informed Cordlife of its intention to suspend the company’s cord blood banking services for one year. Cordlife has 14 days to submit written representations before a final decision is made. If the suspension proceeds, the company will be prohibited from storing new cord blood units (CBUs) but may continue maintaining existing ones.

Audit Findings Raise Concerns

The July 2025 audit revealed multiple operational shortcomings, including:

• Failure to maintain proper governance, incident reporting, and management.
• Storage of CBUs that were not cooled to appropriate cryopreservation temperatures, with no investigation into possible damage.
• Continued use of cord blood collection bags exposed to unsafe temperatures without validation.

MOH noted that key personnel responsible for earlier improvements had resigned without proper handover, while the Clinical Governance Officer (CGO) failed to provide oversight, leading to under-reporting of process failures.

History of Safety Failures

Cordlife has faced regulatory scrutiny since November 2023, when MOH found seven storage tanks exposed to suboptimal temperatures. One tank alone held 2,200 CBUs deemed non-viable, while further tests in April 2024 found another 5,300 CBUs likely unsuitable for transplantation.

Although the facility was allowed to partially resume operations in September 2024 and regained full licensing in January 2025, the latest audit highlights persistent weaknesses in its systems.

Impact on Clients

MOH has directed Cordlife to:

• Replace its current CGO.
• Review all lab records of CBUs collected since January 2025.
• Inform clients of affected units.
• Offer counseling by a qualified haematologist on the clinical implications.

Stored CBUs can only be released for transplantation after haematologist approval. MOH also urged Cordlife to proactively engage clients and address their concerns.

Failed Viability Tests

In addition, samples from three “low-risk” tanks failed recent viability and potency tests, affecting an estimated 12,000 CBUs. Cordlife’s internal analysis could not determine the root cause, prompting MOH to order further investigations.

Wider Implications

MOH has warned that repeated failures could lead to revocation of Cordlife’s operating licence. It also acknowledged that clients may consider transferring their CBUs to other banks, but cautioned that such transfers carry risks. Alternative sources such as bone marrow or donated cord blood remain available for patients requiring stem cell transplants.

The looming suspension marks a critical moment for Cordlife and Singapore’s cord blood banking sector. With tens of thousands of stored CBUs at stake, MOH’s tough stance underscores the priority placed on safety, transparency, and accountability in safeguarding life-saving stem cell resources.

Sources: AsiaOne (2025) , CNA (2025)

Keywords: Cordlife, MOH Singapore, Cord Blood Banking, Suspension, Healthcare Regulation, Stem Cell Transplants