HA follows up on defective PSA reagent recall

Hospital Authority (HA) has initiated an urgent review after discovering that defective prostate-specific antigen (PSA) reagents supplied by Abbott Laboratories Limited produced inaccurate results, potentially leading to misdiagnoses. 

The alert concerns two batches of Alinity i Total PSA Reagent Kits (Lot Nos: 71210FZ00, 71213FZ00) used at Caritas Medical Centre (CMC) and Tuen Mun Hospital (TMH).

The issue came to light on May 27 when Abbott reported complaints about the reagent producing falsely elevated PSA readings—some exceeding 10 percent above actual values. Such errors could prompt unnecessary cancer treatments. 

CMC had already used the faulty kits for 406 tests since April 28, with 70 high-risk patients now being urgently recalled for retesting. The remaining patients will be reassessed during scheduled follow-ups. 

TMH detected the problem before administering any tests.

"PSA results alone don’t diagnose cancer," emphasized an HA spokesperson, noting doctors combine them with physical exams, ultrasounds, and biopsies. No unnecessary procedures or treatment delays have been identified. 

CMC has established a hotline, 5334 0388, for affected patients.

CMC and TMH have now switched to alternative reagents, with the HA confirming that no other facilities used the compromised batches. 

The authority has demanded that Abbott investigate the quality control failure and implement corrective measures, warning of potential penalties. Future shipments will require enhanced quality certifications.

The Department of Health has been notified, as the HA continues monitoring the situation.