December 06, 2023
AABB is aware of findings from a Ministry of Health (MOH) investigation into Cordlife Group Limited (CGL), an AABB-accredited facility located in Singapore.
During the investigation, the MOH found that some of CGL’s cord blood units (CBU) storage tanks had been exposed to temperatures outside the acceptable temperature range. This temperature excursion damaged an estimated 2,220 CBUs from 2,150 clients. Following this investigation, the MOH issued a notice to CGL with a “6-month suspension from accepting new cord blood samples.” Investigations into the remaining storage tanks are ongoing.
After CGL self-reported the suspension and findings of Singapore’s Ministries of Health to AABB as required, AABB’s accreditation department promptly initiated an extensive post-notification protocol. This protocol requires, among many steps, that CGL provide relevant documentation, complete a root cause analysis and develop a comprehensive corrective action plan to address the issues brought forth by the MOH. As part of the ongoing investigation, AABB is continuing to collect relevant information to inform next steps regarding the accreditation status of the facility.
AABB shares concerns that clients of CGL and other AABB-accredited cord blood facilities may have as a result of this situation. AABB is actively investigating these issues and is committed to working with CGL to restore a robust quality system to help prevent future adverse events. We remain steadfast in our commitment to protecting the safety and availability of blood and biotherapies, understanding that conformance to AABB standards delivers optimal levels of quality and safety.