MAUDE Adverse Event Report: ALBA BIOSCIENCE LIMITED (LTD.) ORTHO SERA PAPAIN; SOLUTION, STABILIZED ENZYME

Catalog Number	FD317
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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).
Event or Problem Description
The end user reports false negative results with ortho sera papain product fd317, lot v278742, expiry 30sep25.

• Brand Name: ORTHO SERA PAPAIN
• Common Device Name: SOLUTION, STABILIZED ENZYME
• Manufacturer (Section D): ALBA BIOSCIENCE LIMITED (LTD.); 5 james hamilton way; milton bridge; penicuik, uk EH26 0BF; UK EH26 0BF
• Manufacturer (Section G): ALBA BIOSCIENCE LIMITED (LTD.); 5 james hamilton way; milton bridge; penicuik, uk EH26 0BF; UK EH26 0BF
• Manufacturer Contact: samuele serfilippi ; 5 james hamilton way; milton bridge; penicuik, uk EH26 -0BF ; UK EH26 0BF
• MDR Report Key: 22327432
• Report Number: 3011683976-2025-00006
• Device Sequence Number: 15807089
• Product Code: KSK
• UDI-Device Identifier: 10758750030330
• UDI-Public: 10758750030330
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: BK150246
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: FD317
• Device Lot Number: V278742
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown