규제 업데이트

MHRA published a series of field safety notices between 14‑18 Sep 2026 covering cardiac occluders, circulatory assist catheters, orthopedic instruments, endoscopic needles, imaging systems and diagnostic software.

Beckman Coulter reports a software issue on DxC 500i and DxC 500 AU analyzers where unit settings can revert to defaults without warning.

Blood-to-glycol leakage in the Quantum PureFlow heat exchanger may lead to blood contamination of heater‑coolers; users should be notified.

The UDI label for model p7924a13 incorrectly lists a 40‑inch surface, while the approved configuration is a 36‑inch surface, risking incompatibility with bed frames.

A new patient alert card warns men on finasteride of psychiatric side effects and persistent sexual dysfunction.

Doncaster Pharma reported a Braille embossing error on the outer packaging of certain parallel‑imported Hiprex 1 g tablets to the MHRA.

Milpharm Limited has found a discrepancy in the approved Patient Information Leaflet for its 2 mg Loperamide hydrochloride orodispersible tablets.

Using an IV infusion giving set instead of a blood transfusion set may cause serious patient harm.