MalfunctionKSK

ORTHO SERA PAPAIN

Received Jun 25, 2025

Report 3011683976-2025-00006 · MDR key 22327432

Device

Generic name

Solution, Stabilized Enzyme

Manufacturer

Alba Bioscience Limited (ltd.)

Catalog number

FD317

Lot number

V278742

Product problems

Insufficient Device Problem Information
Insufficient Device Problem Information

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

INVESTIGATION STILL ON GOING AND AS SOON AS WILL BE COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED. ALBA BIOSICENCE REFERENCE NUMBER OF THIS FILE IS (B)(4).

Description of Event or Problem

THE END USER REPORTS FALSE NEGATIVE RESULTS WITH ORTHO SERA PAPAIN PRODUCT FD317, LOT V278742, EXPIRY 30SEP25.